Diabete Mellitus

43

Review clinical trials related to Diabete Mellitus. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Faisalabad Initiative of Research and Management of NCDs

The burden of noncommunicable diseases (NCDs) continues to rise globally, and they have become the leading cause of morbidity and mortality, accounting for over 70% of deaths worldwide¹. Rapid lifestyle transitions and increasing urbanization have disproportionately affected low- and middle-income countries, which now bear a substantial share of the global NCD burden. Pakistan, with a population of 241.5 million, is experiencing a double burden of both communicable diseases and NCDs¹³. The widespread adoption of sedentary lifestyles and unhealthy dietary patterns has contributed to a marked increase in NCDs across the country². According to the WHO Hypertension profile 2025, it is the most prevalent NCD in Pakistan, affecting approximately 42% (41% males and 44% females) of the population¹¹, followed by diabetes, with a reported prevalence of 30.8%¹². Additionally, a recent cross-sectional study among adults attending a tertiary care hospital in Islamabad reported dyslipidemia in 71.6% of men and 78.4% of women, indicating a substantial underlying community burden³. Pakistan also ranks tenth among 188 countries in terms of overweight and obesity prevalence, with nearly half of its population classified as overweight or obese⁴. According to World Health Organization data, 58.1% of Pakistanis are overweight, and 43.9% fall within the obese category⁴. Despite their profound public health and economic implications, efforts to address NCDs remain fragmented and insufficient.17 There remains a significant research gap in community-based NCD screening initiatives, particularly within the suburban and peri-urban communities of Faisalabad creating an unmet need to initiate a preventive strategy at community level to raise awareness about these diseases. This direction will minimize the increasing incidence and prevalence of NCDs and will ensure the quality health outcomes for better future. Timely identification of these diseases through screening is a critical step in reducing their impact on individuals and societies. Early detection enables cost-effective management, improved patient outcomes and a higher quality of life.14 One of the most important ways of reducing deaths from noncommunicable diseases (NCDs) is to control the risk factors that lead to their development.6 In this context, the present study aims to evaluate a community-based project focusing on disease awareness, screening, and structured referral to trained treating physicians for early diagnosis and management of major NCDs. The findings are expected to inform scalable, evidence-based interventions to reduce NCD burden and improve population health outcomes in Pakistan.

Participants needed: 3,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Getz PharmaUpdated: Jun 30, 2026Duration: 3 Months
Eligibility criteria

Not listed

Status: Not yet recruiting

Duodenal pulsENDO as an Early Treatment for Type 2 DM

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Participants needed: 40
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Chinese University of Hong KongUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Duration of T2DM </= 2 years [+2]

Previous treatment with pulsENDO or similar procedure [+18]

Status: Recruiting

Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity

Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Attikon HospitalUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Age ≥18 years. [+2]

Pregnant or breastfeeding patients. [+5]

Status: Recruiting

Oral Health and Systemic Diseases: Survey of General Practitioners

This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of Roma La SapienzaUpdated: May 28, 2026Locations: 1
Eligibility criteria

Licensed General Practitioners currently practicing in Italy [+2]

Physicians not currently practicing as General Practitioners [+3]

Status: Not yet recruiting

Clinical Information System Impact on Hospitalized Patients With Chronic Disease

This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.

Participants needed: 124,240
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of CalgaryUpdated: May 27, 2026Locations: 1
Eligibility criteria

Adults aged 18 years or older at the time of hospital admission. [+6]

Individuals younger than 18 years at the time of hospital admission. [+4]

Status: Not yet recruiting

CGM Experience, Preferences & Blood Glucose Parameters

This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.

Participants needed: 75
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Getz PharmaUpdated: May 26, 2026Duration: 3 Months
Eligibility criteria

Subjects to provide written informed consent prior to any study procedures being... [+5]

History of hypersensitivity to any of the active or inactive ingredients of the... [+9]

Status: Not yet recruiting

Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3

The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory (FCT). This program demonstrated significant improvements in hypertension treatment and control. The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.

Participants needed: 2,800
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Washington University School of MedicineUpdated: May 15, 2026
Eligibility criteria

Adults (≥18 years), [+5]

Individuals who are not yet adults (minors): i.e. infants, children, or teenager... [+1]

Status: Not yet recruiting

The Role Intraoperative Salbutamol Inhaler in Preventing Atelectasis

Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.

Participants needed: 80
Trial details
Phase: Early Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: King Abdullah University HospitalUpdated: May 15, 2026Locations: 1
Eligibility criteria

The study will include patients aged 18-70 years [+2]

cardiac conditions other than hypertension like arrhythmia [+1]

Status: Not yet recruiting

Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.

Participants needed: 9
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: SeraxisUpdated: May 12, 2026
Eligibility criteria

Adult 18 to 65 years with a clinical history of T1D [+4]

Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 m... [+1]

Status: Recruiting

Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab

Bevacizumab, an anti-VEGF (vascular endothelial growth factor) agent used in the treatment of diabetic retinopathy and macular edema associated with retinal vein occlusion, is commonly administered in ophthalmology clinics through intravitreal injection. The systemic use of bevacizumab has been associated with serious conditions such as thromboembolism and bleeding. Although intravitreal bevacizumab is administered in smaller amounts and has limited systemic circulation, it requires repeated injections over a long period. These long-term intravitreal anti-VEGF therapies may lead to adverse outcomes, particularly thromboembolism, due to systemic inhibition of VEGF. However, limited information is available regarding the potential effects of this treatment on the systemic and cardiovascular systems. To evaluate this risk, the study aims to assess changes in the activities of paraoxonase 1 (PON1), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE), which are closely associated with lipid metabolism, coronary artery disease, and atherosclerosis. These enzymes are known biomarkers of cardiovascular health and play significant roles in protection against oxidative stress and inflammation. For this purpose, a case-control study is planned. Serum BChE and PON1 activities, as well as triglyceride (TG)/high-density lipoprotein (HDL) and TG/glucose ratios, will be determined in patients receiving repeated intravitreal bevacizumab injections and in control groups, and cardiovascular disease risk will be assessed. This study may help us better understand the safety profile of this treatment by revealing the effects of bevacizumab on serum enzyme activities and cardiovascular risk factors. These findings could contribute to optimizing treatment strategies in clinical practice.

Participants needed: 180
Trial details
Age: 50-80Biological sex: AllType: ObservationalSponsor: Ataturk UniversityUpdated: Apr 24, 2026Locations: 1
Eligibility criteria

Age ≥ 55 years. [+3]

Chronic inflammatory disease. [+3]

Status: Not yet recruiting

Developing a Colonoscopy Preparation Protocol for Patients With Diabetes

Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied. Studies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation. This study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.

Participants needed: 40
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Queen's UniversityUpdated: Apr 24, 2026Locations: 1
Eligibility criteria

Patients Age over the age of 18 [+2]

Patients without diabetes [+11]

Status: Recruiting

Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus

The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Participants needed: 340
Trial details
Age: 19+Biological sex: AllType: InterventionalSponsor: VUNO Inc.Updated: Apr 13, 2026Locations: 1
Eligibility criteria

Adults aged 19 years or older. [+2]

A prior diagnosis of diabetic retinopathy at the time of screening. [+4]

Status: Not yet recruiting

The Effect Of Color Rotation Technique Training On İnsülin Self-management İn Diabetic Patients.

Diabetes mellitus (DM) is a chronic disease characterized by impaired carbohydrate, protein, and lipid metabolism, resulting from a deficiency of insulin hormone secreted by the pancreas and/or the body's inability to utilize it even when sufficient insulin is secreted. As a frequently observed chronic disease, diabetes is a significant public health problem; if left uncontrolled, it can lead to serious complications and negatively impact quality of life.Individual management of treatment is crucial for successful treatment and glycemic control in diabetes. Due to the complexity of diabetes management related to insulin use, diabetics require greater self-care skills. Nurses play a crucial role in developing desired self-management behaviors in individuals with diabetes, supporting them, and meeting their needs.

Participants needed: 112
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Tokat Gaziosmanpasa UniversityUpdated: Apr 8, 2026
Eligibility criteria

Between the ages of 18-65 [+8]

Not using insulin treatment-Using an insulin pump [+2]

Status: Not yet recruiting

Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes

This study evaluates the effectiveness and safety of tributyrin supplementation in patients with type 2 diabetes mellitus (T2DM) who are at increased risk of cardiovascular disease. Type 2 diabetes is commonly associated with poor blood sugar control, chronic inflammation, oxidative stress, and an increased risk of heart disease. Tributyrin is a dietary supplement that acts as a precursor to butyrate, a compound known for its anti-inflammatory and metabolic benefits. It may help improve blood sugar levels, reduce inflammation, and lower cardiovascular risk. In this randomized, double-blind, controlled clinical trial, participants will receive either tributyrin in addition to their standard diabetes treatment or standard therapy alone. The study will assess whether tributyrin improves glycemic control, inflammation, oxidative stress, lipid profile, and overall cardiovascular risk while maintaining safety and tolerability.

Participants needed: 60
Trial details
Phase: Phase 3Age: 18-70Biological sex: AllType: InterventionalSponsor: Ain Shams UniversityUpdated: Mar 31, 2026Locations: 1
Eligibility criteria

• Diagnosed with Type 2 DM for ≥ 1 year [+3]

• Established cardiovascular disease (history of MI, stroke, or revascularizatio... [+5]

Status: Not yet recruiting

Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters

Diabetes represents one of the major chronic diseases, with diabetic ulcers being a significant adverse prognosis. Approximately 80% of lower limb amputations are attributed to diabetic foot ulcers, which constitute a primary cause of patient disability and mortality, while also imposing a substantial burden on healthcare systems. Although standardized Western medical protocols for diabetic foot management exist, clinical outcomes remain suboptimal. The amputation rate due to diabetic foot ulcers continues to rise annually, underscoring the urgent need for novel and effective interventions to address this condition. Quantitative assessment of cutaneous biomechanical parameters may indirectly reflect the cumulative damage inflicted by diabetes on foot tissues. Such evaluation provides critical guidance for predicting susceptibility to recurrent ulceration and determining the necessity of enhanced offloading strategies to prevent ulcer development. By applying specific mechanical loads to the skin and measuring deformation, rebound characteristics, and displacement dynamics under pressure, it becomes possible to quantitatively evaluate parameters such as elastic modulus and viscoelastic properties. This case-control study aims to investigate the feasibility of utilizing plantar skin quantitative mechanical parameters as objective biomarkers for biomechanical impairment in diabetic foot. Furthermore, it seeks to establish a standardized operating procedure (SOP) for quantitative measurements tailored to diabetic foot scenarios. The study is designed to bridge critical evidence gaps between theoretical consensus and clinically applicable quantitative tools, demonstrating clear innovation and potential clinical value.

Participants needed: 200
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Peking University Third HospitalUpdated: Mar 13, 2026
Eligibility criteria

For healthy one: Fasting blood glucose < 6.1 mmol/L and glycated hemoglobin < 6.... [+1]

For healthy one: (1) History of foot surgery, trauma, or fractures resulting in... [+1]

Status: Not yet recruiting

AI-Based Diabetic Foot Recurrence Cohort

Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies-such as risk stratification, inflexible follow-up intervals, and insufficient compliance management-often resulting in suboptimal outcomes. High-risk patients prone to recurrence may not be followed up frequently enough for early detection, while low-risk patients may undergo unnecessary visits, increasing burdens on both patients and healthcare providers. This inefficiency contributes significantly to the persistently high rates of disability and mortality among recurrent DFU patients. Establishing an individualized follow-up strategy for DFU, supported by advanced technology to address core bottlenecks such as delayed recurrence warnings and inadequate home-based management, represents an effective technical pathway to tackle these issues. Our center proposes to develop a dedicated DFU cohort with comprehensive active follow-up and a multimodal database encompassing well-defined indicators. We aim to explore a high-risk foot grading system for preventing DFU recurrence and design targeted follow-up protocols. By leveraging AI technology, we intend to build a wound warning system capable of identifying DFU recurrence. Furthermore, we seek to establish a telemedicine and AI-assisted, patient-centered home-based self-management framework for early warning and prevention of DFU recurrence.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Peking University Third HospitalUpdated: Mar 5, 2026Locations: 1Duration: 3 Months
Eligibility criteria

The patient must be aged 18 years or older; have a confirmed diagnosis of type 1...

Inability of the patient to cooperate or presence of psychiatric disorders; At t...

Status: Recruiting

"Erectile Function After PCI in MI and Non-MI Patients"

The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.

Participants needed: 100
Trial details
Age: 30-75Biological sex: MaleType: ObservationalSponsor: Kırıkkale UniversityUpdated: Mar 3, 2026Locations: 1Duration: 6 Months
Eligibility criteria

Male patients aged 30-75 years [+9]

Known malignancy (active or recently treated) [+16]

Status: Not yet recruiting

Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients

The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve health outcomes among adult patients with diabetes receiving care at tertiary hospitals in Northwest Amhara, Ethiopia. The main questions it aims to answer are: * Does a telemedicine-based behavioral intervention improve glycemic control (HbA1c) among diabetic patients? * Does the intervention improve medication adherence among diabetic patients? * Does the intervention improve diabetes self-care practices? * Does the intervention increase patients' knowledge about diabetes? * Does the intervention reduce hospital admissions among diabetic patients? We will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves glycemic control, medication adherence, self-care practices, diabetes knowledge, and reduces hospital admissions. Participants will: * Receive structured telephone-based education every two weeks for three months (intervention group only) * Participate in 30-50-minute counseling sessions during the first call and 15-30 Minutes sessions during subsequent calls (intervention group only) * Receive education on diabetes basics, nutrition and meal planning, physical activity, medication management, blood glucose monitoring, complication prevention, and psychosocial support (intervention group only) * Engage in interactive discussions and receive individualized guidance from trained nurses (intervention group only) * Continue routine diabetes care at the hospital (both groups)

Participants needed: 320
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Bahir Dar UniversityUpdated: Feb 20, 2026
Eligibility criteria

Adult patients ≥18 with diabetes mellitus who have follow-up for ≥6 months at th... [+2]

Participants who have coexisting severe mental health illnesses [+3]

Status: Recruiting

Assessing the Effectiveness of Large Language Model (LLM)-Enabled Nurse Treatment Planning in 2 Indian Districts

The goal of this clinical trial is to learn whether AI-enabled, nurse-led treatment planning can improve the quality of clinical reasoning and management compared with standard physician-led care in adult primary care patients (≥18 years) presenting with hypertension, diabetes mellitus, fever, breathlessness, or musculoskeletal pain in rural and semi-urban India. The main questions it aims to answer are: * Does a nurse + large language model (LLM) consultation achieve non-inferior clinical quality scores compared with a standard doctor consultation? * Is AI-assisted nurse-led care acceptable and satisfactory to patients in primary healthcare settings? Researchers will compare nurse + LLM-led consultations with physician-led standard-of-care consultations within the same participant to see if the AI-enabled nurse model delivers comparable or improved clinical reasoning and treatment planning. Participants will: * Receive two sequential consultations for the same visit (one with a nurse using an AI tool and one with a physician, order randomized). * Have both consultations audio recorded for blinded clinical quality assessment. * Complete a brief exit survey on communication, trust, and satisfaction after the AI-assisted nurse consultation.

Participants needed: 672
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sarah NabiaUpdated: Feb 25, 2026Locations: 1
Eligibility criteria

Adults aged ≥18 years [+8]

Inability to provide informed consent due to cognitive impairment (e.g., dementi... [+2]

Status: Not yet recruiting

Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

This Phase I randomized clinical trial aims to investigate the short-term effects of three commonly prescribed statins (atorvastatin, rosuvastatin, and simvastatin) at different dose levels on blood glucose homeostasis in healthy volunteers. The study will assess changes in fasting blood glucose, insulin, and C-peptide levels following two days of statin administration under controlled conditions. The research seeks to provide comparative data on the potential diabetogenic effects of these medications.

Participants needed: 100
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: Shaheed Benazir Bhutto University Sheringal Dir UpperUpdated: Jan 30, 2026Locations: 2
Eligibility criteria

healthy volunteers [+2]

Participants with a history of diabetes mellitus [+2]

Status: Recruiting

Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing

Participants needed: 30
Trial details
Phase: Phase 4Age: 45-85Biological sex: AllType: InterventionalSponsor: BioXTekUpdated: Jan 8, 2026Locations: 2
Eligibility criteria

Patient has signed the informed consent form. [+12]

Hemoglobin A1c (HbA1c) level is > 10%. [+15]

Status: Not yet recruiting

Assessment of Antithyroglobulin Antibody Levels Among Diabetic Patients

Assessment of antithyroglobulin antibody (anti Tg) level among diabetic patients explores the intersection between autoimmune thyroid disease and diabetes mellitus. Autoimmune thyroiditis and diabetes frequently coexist, and anti Tg is one of the main markers used to document thyroid autoimmunity.(1,2) Thyroglobulin is a large iodinated glycoprotein produced by thyroid and serves as the precursor for thyroid hormone synthesis. Damage to thyroid tissue in autoimmune thyroiditis leads to production of autoantibodies against thyroglobulin (Tg)(1,3). Anti Tg is therefore considered serologic hallmarks of autoimmune thyroiditis. The presence of this antibody may also be used to monitor thyroid damage progression and predict the development of overt hypothyroidism in at risk populations(1,3). Type 1 diabetes mellitus (T1DM) is an organ specific autoimmune. Because of shared genetic susceptibility and overlapping immune mechanisms, patients with T1DM have a markedly increased prevalence of autoimmune thyroiditis compared with the general population. International guidelines support routine screening for thyroid autoantibodies and thyroid function in T1DM to enable early detection of subclinical thyroid dysfunction(2,4). . A study reported that, among 60 T1DM patients without known thyroid disease, 16.7% were positive for anti Tg, and subclinical or overt hypothyroidism was present in a substantial fraction of this antibody positive individuals. Other series similarly show that thyroid autoantibodies are common in T1DM and that their presence predicts later thyroid dysfunction. (5,6). Increasing evidence indicates that type 2 diabetes mellitus (T2DM) is also associated with a higher prevalence of thyroid autoantibodies than nondiabetic controls in many studies(1,7). In a study including 72 T2DM patients, 20.8% had either anti TPO or anti Tg positivity, and 8.3% had isolated anti Tg antibodies, with rates comparable to or higher than those reported in regional control populations. A study of female T2DM patients found anti Tg in 61.3% of cases compared with no positives in the control group, and more than half of hypothyroid diabetic patients had anti Tg positivity, suggesting a significant autoimmune contribution to thyroid dysfunction in some T2DM cohorts. (2,8). Autoimmune clustering means that diabetic patients, are predisposed to additional organ specific autoimmune diseases, including autoimmune thyroiditis. Screening for anti Tg provides a more complete picture of thyroid autoimmunity. (2,8)

Participants needed: 112
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Jan 15, 2026
Eligibility criteria

Adult aged 18-80 years, both genders. [+1]

History of thyroid disease [+4]

Status: Recruiting

Targeting Neurovascular Coupling in Cognitive Decline Via Nitrate-Based Supplementation

Diet is established among the most relevant adjustable variables of human health in modern societies. The recognition by the World Health Organization of cognitive impairment and dementia associated with aging as one of the major public health challenges of our time, highlights the imperative need for a more comprehensive understanding of how different aspects of lifestyle, in particular diet, affect neural function and consequent cognitive performance throughout lifespan. The brain is endowed with fine mechanisms for a precise spatial and temporal control of cerebral blood flow (CBF) according to neural activity, the neurovascular coupling (NVC). Mounting evidence from preclinical and human studies demonstrate that NVC dysfunction is a key early factor contributing to the pathogenesis of cognitive decline and vascular cognitive impairment (VCI) in aging and conditions associated with accelerated microvascular aging, such as cerebral small vessel disease (cSVD). Failure at any part of the NVC pathway disrupts CBF resulting in catastrophic depletion of oxygenation and energy supply to brain cells, and, in the long run, to neuronal dysfunction and cognitive impairment. The investigators have shown that nitric oxide (NO) synthesized by neuronal nitric oxide synthase (nNOS) is a direct mediator of NVC and that decreased bioavailability of NO along aging compromised NVC and reduced local CBF. Shortly after the identification of nNOS as a source of NO for vasodilation in the brain, an alternative pathway for NO production independent of nNOS, relying on the sequential reduction of nitrate, the nitrate:nitrite:NO pathway, was unveiled. Nitrate consumed in green leafy vegetables as part of a normal diet is bioactivated to nitrite and both compounds are permanent constituents of blood/tissues in animal species, influencing CBF and resulting in improvements in learning and memory in rodents and VCI patients. However, a critical question remains on whether NO produced from nitrite is functionally linked to neuronal activation. This is key to understanding whether dietary nitrate can be linked to neuronal-dependent CBF increases and cognitive performance. The investigators and others have shown that upon excitatory stimulation, ascorbate is released from neurons being available for nitrite reduction and our preliminary data supports that NO bioavailability and CBF might be maintained independently of nNOS by the reduction of nitrite to NO in the brain extracellular space upon neuronal activation (unpublish data). This innovative mechanism functionally links the production of NO from nitrite to neuronal activation, triggering CBF increases and maintaining an operative NVC. A further facet is that, bridging diet and cognitive performance, this mechanism incorporates modulatory elements which is open to adjustment by diet via nitrate. Thus, in this pilot trial a proof of concept study will be conducted to investigate the clinical impact of a dietary nitrate supplementation intervention in a clinical population with VCI due to small vessel disease, as measured by changes on NVC and cognitive performance. The investigators hypothesise that functional NVC is maintained operative in VCI patients by increasing NO bioavailability in the extracellular space of the brain through a nitrate -rich diet that, in turn, supports an adequate CBF in response to neuronal activation, modulating the molecular mechanisms and cognitive performance of disease-related physiological and cognitive markers.

Participants needed: 25
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of CoimbraUpdated: Jan 9, 2026Locations: 2
Eligibility criteria

Formal diagnosis of cerebral small vessel disease (grades 1 to 3 in the Age-Rela... [+2]

Vascular diseases other than cerebral Small Vessel Disease (cSVD); [+13]

Status: Recruiting

Prediction Model for the Risk of Developing Foot Ulcers in Diabetes

Introduction Foot ulcers in diabetes mellitus (DM) are a common and serious complication that can lead to infection, amputation, and increased mortality. Early identification of patients at high risk is crucial in order to implement preventive measures at an early stage. The number of people with DM is increasing globally, from 540 million in 2021 to an estimated 780 million by 2045. Foot ulcers cause considerable suffering for the individual and entail substantial costs for the healthcare system. Despite national guidelines recommending regular, structured foot examinations and risk classification to assess the risk of developing foot ulcers, current risk models do not take into account the complex interactions between risk factors and socioeconomic factors such as marital status, level of education, and place of residence. Data-driven advances and artificial intelligence (AI) offer new opportunities to refine risk identification, but their use in predicting the risk of diabetic foot ulcers remains limited. The need for foot screening is considerable. In Sweden, there are approximately 600,000 patients with DM, and half of them live with an increased risk due to nerve damage in the feet. This means that, based on risk level, around 300,000 patients in Sweden may require preventive interventions, including medical foot care, customised footwear, and access to specialist care for those with foot ulcers. Improved preventive efforts are emphasised in the person-centred and integrated care pathway for people with diabetes at high risk of foot ulcers. However, accurate identification of foot ulcer risk is currently lacking. Prevention leads not only to good quality of life for the individual but also to reduced healthcare costs. Estimates by Ragnarsson Tennvall show that a hard-to-heal ulcer costs approximately SEK 100,000 per year, while an amputation costs around SEK 300,000-500,000. Given a prevalence of foot ulcers of 5% among patients with diabetes, the annual cost of ulcer care amounts to SEK 3 billion. In addition, there are costs of approximately SEK 750 million for amputations, according to data from the quality register SwedAmp. The aim of the study is to develop, test, and validate prediction models (statistical and AI-based) to identify patients with DM who are at risk of developing foot ulcers. The models will be based on retrospective electronic health record data from primary care in the Västra Götaland Region (VGR), as well as data from Statistics Sweden (SCB) concerning demographic factors such as marital status, level of education, occupation, and place of residence. Methods The study has two methodological approaches: AI-based modelling and statistical modelling. AI-based approach Machine learning models will be developed to predict patients at risk of developing diabetic foot ulcers. The models will be trained using cross-validation on a large dataset in which variables will be iteratively excluded. Conformal prediction will be used to quantify uncertainty in patient-level predictions. The resulting models will be analysed to identify the strongest predictors and will be compared with classical statistical modelling and findings from the literature. Steps in AI modelling: Data extraction: Electronic health record data from primary care in VGR, supplemented with sociodemographic data from SCB. Data processing: Use of, among other variables, diagnostic codes (ICD-10), healthcare interventions (KVÅ codes), visit types, visit frequency, ECG parameters, and free-text data to construct predictors. Model development: Prediction models will be developed and trained using cross-validation. Measures of uncertainty will be generated using conformal prediction. Validation: A separate cohort will be used to test model performance (sensitivity, specificity, positive predictive value \[PPV\]). Interpretation: The models will be reviewed for transparency and clinical interpretability in collaboration with patient representatives, clinicians, and researchers. The results of the statistical and AI-based models will be compared with regard to their respective strengths and weaknesses. Statistical modelling Two populations will be analysed: patients with diabetes without foot ulcers and patients with diabetes with foot ulcers. Co-variation and causal relationships between risk factors and foot ulcers will be identified. A model describing causal pathways leading to ulcer development will be developed, and its certainty and uncertainty will be analysed.

Participants needed: 100,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sahlgrenska University HospitalUpdated: Dec 29, 2025Locations: 1
Eligibility criteria

Adult patients aged 18 years or older at the time of inclusion [+3]

Patients younger than 18 years of age at the time of diabetes diagnosis or presc... [+2]

Status: Not yet recruiting

Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.

Participants needed: 75
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Dec 29, 2025Locations: 1
Eligibility criteria

Other causes of neuropathy (e.g., CIDP, trauma, toxins, vitamin deficiencies), a... [+1]