[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620942":3},{"organization":4,"outcomesModule":7,"designInfo":158,"detailedDescription":157,"studyPopulation":157,"armGroups":165,"interventions":177,"overallOfficials":157,"centralContacts":157,"locations":187,"responsibleParty":207,"collaborators":211,"id":215,"slug":157,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":216,"sex":222,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":157,"studyType":228,"phases":229,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":189,"whyStopped":157,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},{"fullName":5,"class":6},"Cambridge University Hospitals NHS Foundation Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":157},[9],{"measure":10,"description":11,"timeFrame":12},"Ambulatory systolic blood pressure","Change in daytime ambulatory systolic blood pressure in the weight loss arm","Baseline to week 24",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,103,105,107,109,111,113,115,117,119,121,124,126,128,130,133,136,138,140,142,144,146,148,150,152,155],{"measure":15,"description":16,"timeFrame":12},"Ambulatory diastolic blood pressure","Change in daytime ambulatory diastolic blood pressure in the weight loss arm",{"measure":18,"description":19,"timeFrame":12},"Clinic systolic blood pressure","Changes in clinic systolic blood pressure in the weight loss arm",{"measure":21,"description":22,"timeFrame":12},"Clinic diastolic blood pressure","Changes in clinic diastolic blood pressure in the weight loss arm",{"measure":24,"description":25,"timeFrame":12},"Clinic mean arterial pressure","Changes in clinic mean arterial pressure in the weight loss arm",{"measure":27,"description":28,"timeFrame":12},"Unattended systolic blood pressure","Changes in unattended systolic blood pressure in the weight loss arm",{"measure":30,"description":31,"timeFrame":12},"Unattended diastolic blood pressure","Changes in unattended diastolic blood pressure in the weight loss arm",{"measure":33,"description":34,"timeFrame":12},"Unattended mean arterial pressure","Changes in unattended mean arterial pressure in the weight loss arm",{"measure":36,"description":37,"timeFrame":12},"Body weight","Changes in body weight in the weight loss arm",{"measure":39,"description":40,"timeFrame":12},"Body fat","Changes in body fat in the weight loss arm",{"measure":42,"description":43,"timeFrame":12},"Waist:hip ratio","Changes in waist:hip ratio in the weight loss arm",{"measure":45,"description":46,"timeFrame":12},"Cardiac output","Changes in cardiac output in the weight loss arm",{"measure":48,"description":49,"timeFrame":12},"Peripheral vascular resistance","Changes in peripheral vascular resistance in the weight loss arm",{"measure":51,"description":52,"timeFrame":12},"Pulse wave analysis \u002F pulse wave velocity","Changes in markers of pulse wave analysis and pulse wave velocity in the weight loss arm",{"measure":54,"description":55,"timeFrame":12},"Heart rate variability","Changes in heart rate variability in the weight loss arm",{"measure":57,"description":58,"timeFrame":12},"Renin","Changes in plasma renin in the weight loss arm",{"measure":60,"description":61,"timeFrame":12},"Aldosterone","Changes in plasma aldosterone in the weight loss arm",{"measure":63,"description":64,"timeFrame":12},"Plasma metanephrines","Changes in plasma metanephrines in the weight loss arm",{"measure":66,"description":67,"timeFrame":12},"Leptin","Changes in leptin in the weight loss arm",{"measure":69,"description":70,"timeFrame":12},"Insulin","Changes in plasma insulin in the weight loss arm",{"measure":72,"description":73,"timeFrame":12},"Lipid profile","Changes in the lipid profile in the weight loss arm",{"measure":75,"description":76,"timeFrame":12},"HbA1C","Changes in HbA1C in the weight loss arm",{"measure":78,"description":79,"timeFrame":12},"Estimated glomerular filtration rate","Changes in eGFR in the weight loss arm",{"measure":81,"description":82,"timeFrame":12},"N-terminal pro-B-type natriuretic peptide","Changes in NT-proBNP in the weight loss arm",{"measure":84,"description":85,"timeFrame":12},"Urine albumin:creatinine ratio","Change in urine albumin:creatinine ratio in the weight loss arm",{"measure":87,"description":88,"timeFrame":12},"24-hour urine sodium","Change in 24-hour urine sodium in the weight loss arm",{"measure":90,"description":91,"timeFrame":12},"24-hour urine aldosterone","Change in 24-hour urine aldosterone in the weight loss arm",{"measure":93,"description":94,"timeFrame":12},"Antihypertensive medications","Change in number of antihypertensive medications",{"measure":96,"description":97,"timeFrame":12},"Quality of life measures","Changes in quality of life questionnaire scores in the weight loss arm",{"measure":10,"description":99,"timeFrame":100},"Between-group comparison in ambulatory sytolic blood pressure","Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)",{"measure":15,"description":102,"timeFrame":100},"Between-group comparison in ambulatory diastolic blood pressure",{"measure":18,"description":104,"timeFrame":100},"Between-group comparison in clinic systolic blood pressure",{"measure":21,"description":106,"timeFrame":100},"Between-group comparison in clinic diastolic blood pressure",{"measure":24,"description":108,"timeFrame":100},"Between-group comparison in clinic mean arterial pressure",{"measure":27,"description":110,"timeFrame":100},"Between-group comparison in unattended systolic blood pressure",{"measure":30,"description":112,"timeFrame":100},"Between-group comparison in unattended diastolic blood pressure",{"measure":33,"description":114,"timeFrame":100},"Between-group comparison in mean arterial pressure",{"measure":36,"description":116,"timeFrame":100},"Between-group body weight",{"measure":39,"description":118,"timeFrame":100},"Between-group comparison in body fat",{"measure":42,"description":120,"timeFrame":100},"Between-group comparison in waist:hip ratio",{"measure":45,"description":122,"timeFrame":123},"Between-group comparison in cardiac output","At week 24 (weight loss arm) and 6 months (standard of care arm)",{"measure":48,"description":125,"timeFrame":123},"Between-group comparison in peripheral vascular resistance",{"measure":51,"description":127,"timeFrame":123},"Between-group comparison in markers of pulse wave analysis and pulse wave velocity",{"measure":54,"description":129,"timeFrame":123},"Between-group comparison in heart rate variability",{"measure":131,"description":132,"timeFrame":100},"Plasma renin","Between-group comparison in plasma renin",{"measure":134,"description":135,"timeFrame":100},"Plasma aldosterone","Between-group comparison in plasma aldosterone",{"measure":63,"description":137,"timeFrame":100},"Between-group comparison in plasma metanephrines",{"measure":72,"description":139,"timeFrame":100},"Between-group comparison in lipid profile",{"measure":75,"description":141,"timeFrame":100},"Between-group comparison in HbA1C",{"measure":78,"description":143,"timeFrame":100},"Between-group comparison in eGFR",{"measure":81,"description":145,"timeFrame":100},"Between-group comparison in NT-proBNP",{"measure":84,"description":147,"timeFrame":100},"Between-group comparison in urine albumin:creatinine ratio",{"measure":87,"description":149,"timeFrame":100},"Between-group comparison in 24-hour urine sodium",{"measure":90,"description":151,"timeFrame":100},"Between-group comparison in 24-hour urine aldosterone",{"measure":153,"description":154,"timeFrame":100},"Number of antihypertensive medications","Between-group comparison in the number of anti-hypertensive medications",{"measure":96,"description":156,"timeFrame":123},"Between-group comparison in quality of life questionnaire scores",null,{"allocation":159,"interventionModel":160,"interventionModelDescription":161,"primaryPurpose":162,"observationalModel":157,"timePerspective":157,"maskingInfo":163},"RANDOMIZED","PARALLEL","The study will utilise a modified trial within cohort (TwiC) design for patients under the hypertension\u002Fclinical pharmacology clinic. Those who meet the eligibility criteria for randomisation will be randomised to being approached for either:\n\n(i) 6 months of treatment with a combined GLP-1\u002FGIP receptor agonist, Tirzepatide \\[Group A - Weight loss arm\\] (ii) Standard anti-hypertensive treatment and attendance at a 6-month combined research\u002Fclinical follow-up visit \\[Group B - Standard of Care (SoC) arm\\].","TREATMENT",{"masking":164,"maskingDescription":157,"whoMasked":157},"NONE",[166,172],{"label":167,"type":168,"description":169,"interventionNames":170},"Tirzepatide [weight loss arm]","EXPERIMENTAL","6 months of treatment with a combined GLP-1\u002FGIP receptor agonist, tirzepatide",[171],"Drug: Tirzepatide",{"label":173,"type":174,"description":157,"interventionNames":175},"Lifestyle advice and anti-hypertensive medications [standard of Care arm]","ACTIVE_COMPARATOR",[176],"Drug: Anti-Hypertensive medications",[178,183],{"type":179,"name":180,"description":181,"armGroupLabels":182,"otherNames":157},"DRUG","Tirzepatide","2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks",[167],{"type":179,"name":184,"description":185,"armGroupLabels":186,"otherNames":157},"Anti-Hypertensive medications","Anti-hypertensive drug therapy as per local and national guidelines",[173],[188],{"facility":5,"status":189,"city":190,"state":191,"zip":192,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":200,"contacts":201},"RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":196,"coordinates":197},"Point",[198,199],0.11667,52.2,{"lat":199,"lon":198},[202],{"name":203,"role":204,"phone":205,"phoneExt":157,"email":206},"James Goodman, MRCP PhD","CONTACT","+44 01223 336806","james.goodman11@nhs.net",{"type":208,"investigatorFullName":209,"investigatorTitle":210,"investigatorAffiliation":5,"oldNameTitle":157,"oldOrganization":157},"PRINCIPAL_INVESTIGATOR","James Goodman","Consultant Physician and Clinical Pharmacologist",[212],{"name":213,"class":214},"National Institute for Health Research, United Kingdom","OTHER_GOV","100620942",false,"NCT07364175","A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults","Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study","SOLUTION-Pilot","Eligibility criteria for randomisation\n\nInclusion Criteria:\n\n* Aged 18 to 40 years (inclusive)\n* Body mass index (BMI) ≥27 kg\u002Fm2\n* Clinical diagnosis of primary (essential) hypertension as per NICE guidance\n* Unattended brachial SBP ≥135 and\u002For DBP ≥85 mmHg and \\\u003C160\u002F100 mmHg\n* Maximum of one antihypertensive medication\n\nExclusion Criteria:\n\n• Anything in medical notes suggesting unsuitable in the opinion of the investigator\n\nEligibility criteria for participation in weight loss arm\n\nInclusion criteria:\n\n* Written informed consent\n* Aged 18 to 40 years (inclusive)\n* Body mass index ≥27 kg\u002Fm2\n* Clinical diagnosis of primary (essential) hypertension as per NICE guidance\n* Unattended brachial SBP ≥135 and\u002For DBP ≥85 mmHg and \\\u003C160\u002F100 mmHg\n* Maximum of one antihypertensive medication\n\nExclusion criteria:\n\nThe presence of any of the following will preclude participant inclusion:\n\n* Known or suspected secondary hypertension\n* Hypersensitivity to any of the study drugs or excipients\n* Currently taking drugs likely to have interactions with tirzepatide\n* Diagnosis of type 1 or type 2 diabetes mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists\n* Prior or planned surgical, endoscopic and\u002For device-based therapy treatment for obesity\n* Self-reported, intentional or unintentional, change in body weight (over \\~10%) within \\~three months of screening\n* Known heart failure or clinically significant valvular heart disease\n* Implanted pacemaker or implantable cardioverter defibrillator (ICD)\n* Second or third-degree AV block, sino-atrial block, sick sinus syndrome\n* Known active malignancy including thyroid cancer\n* Known renal impairment (creatinine \\>150µmol\u002FL)\n* Clinically significant neurological disease\n* History of scleroderma\n* Participants on anticoagulant therapy\n* Known history of pancreatitis\n* Known inflammatory bowel disease\n* History of gallstones (unless previous cholecystectomy)\n* Severe gastroparesis or gastric emptying abnormality\n* Family history of multiple endocrine neoplasia\n* Needle-phobia\n* Planned pregnancy, current pregnancy, or breastfeeding\n* Current involvement in the active treatment phase of other research studies\n* Any other clinical reason which may preclude entry in the opinion of the investigator","ALL","18 Years","40 Years",{"count":226,"type":227},60,"ESTIMATED","INTERVENTIONAL",[230],"NA","Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom. Obesity is also a serious and ongoing epidemic, with global obesity rates having more than tripled in men and doubled in women, since 1975. In the United Kingdom, 64% of the adult population are overweight or obese. Hypertension and obesity share a well-established association, with obesity being responsible for the development of hypertension in 40-78% of cases. In young adults, this link between body size and blood pressure (BP) is much stronger that in older adults. Since overweight and obesity are among the most common and modifiable causes of high BP, weight loss induced by lifestyle-changes is recommended for overweight or obese patients with hypertension. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not maintained in the majority of cases. A meta-analysis of randomised controlled trials demonstrated that lifestyle-interventions lead to an average net weight reduction of 5.1 kg, accompanied by a significant, but modest, \\~4 mmHg reduction in BP. Weight loss interventions could play a crucial role in the treatment of obesity-related hypertension in young adults.\n\nGlucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, originally developed for the treatment of type 2 diabetes, are safe and clinically effective anti-obesity drugs. Recent data show a 10-20% placebo-adjusted reduction in body weight in overweight or obese adults without diabetes using the GLP-1 analogue semaglutide or the dual GLP-1\u002FGIP receptor agonist tirzepatide, with the majority of weight loss achieved within the initial six months. The substantial weight loss induced by these drugs is accompanied by a significant reduction in BP. Two recent meta-analyses showed that semaglutide is associated with a \\~5 mmHg placebo-adjusted reduction in clinic systolic BP (SBP). A sub-study of the SURMOUNT-1 trial reported a \\~10 mmHg reduction in 24-h ambulatory SBP with tirzepatide. Most participants in these studies were normotensive or had well-controlled hypertension. Furthermore, antihypertensive medication use declined amongst those receiving anti-obesity drugs meaning the BP-lowering effect of weight loss, elicited by these drugs, is probably underestimated. These data suggest that the new anti-obesity drugs could be effective in managing overweight or obesity-related hypertension. Furthermore, it may be possible to cure hypertension in at least some young adults, removing the need for life-long antihypertensive treatment. However, the magnitude and time course of BP reduction elicited by these new anti-obesity drugs remain uncertain.\n\nThe primary aim of this feasibility study is to assess the extent and trajectory of BP reduction achieved through intensive weight loss in overweight or obese adults with stage 1 hypertension and compare this to current standard of care measures which uses anti-hypertensive medications and lifestyle advice. The study will utilise a modified trial within cohort approach, using patients based within the clinical pharmacology\u002Fhypertension service at Addenbrooke's Hospital, Cambridge.",[233,234],"Hypertension","Obesity & Overweight",[236,237,238,239,240],"hypertension","obesity","overweight","tirzepatide","GLP-1","2026-01-28",{"date":243,"type":244},"2026-01-29","ACTUAL",{"date":246,"type":227},"2026-01",{"date":248,"type":227},"2029-01",{"name":5,"class":6},1]