[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540754":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":54,"centralContacts":58,"locations":68,"responsibleParty":80,"collaborators":39,"id":83,"slug":39,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":39,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":108,"overallStatus":112,"whyStopped":39,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Vericiguat","EXPERIMENTAL","The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.",[13,14,15,16,17],"Drug: Vericiguat 10 MG","Other: Insulin Sensitivity Test","Other: Resting Energy and Exercise Energy Expenditure Assessment","Other: White Adipose Tissue Biopsy","Other: MRI-PET Scan for Brown Adipose Tissue Volume Assessment",{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.",[23,14,15,16,17],"Other: Placebo",[25,31,35,40,46,50],{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"DRUG","Vericiguat 10 MG",[9],[30],"Vericiguat Arm",{"type":6,"name":19,"description":21,"armGroupLabels":32,"otherNames":33},[19],[34],"Placebo Arm",{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Insulin Sensitivity Test","An assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions.",[9,19],null,{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Resting Energy and Exercise Energy Expenditure Assessment","Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.",[9,19],[45],"Resting and Exercise Induced Energy Expenditure Test",{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":39},"White Adipose Tissue Biopsy","Participants who consent to participate in the exploratory aim will undergo WAT biopsy to assess UCP1 gene expression from the collected biospecimens, at baseline and after 12 weeks of pharmacological interventions.",[9,19],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":39},"MRI-PET Scan for Brown Adipose Tissue Volume Assessment","Participants who consent to participate in the exploratory aim will undergo PET\u002FMR to BAT volume at baseline and after 12 weeks of pharmacological interventions.",[9,19],[55],{"name":56,"affiliation":5,"role":57},"Pankaj Arora, MD, FAHA","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":39,"email":63},"Nehal Vekariya, MS","CONTACT","2059347173","nvekariya@uabmc.edu",{"name":65,"role":61,"phone":66,"phoneExt":39,"email":67},"Naman Shetty, MD","2059755826","nsshetty@uabmc.edu",[69],{"facility":5,"status":39,"city":70,"state":71,"zip":72,"country":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":39},"Birmingham","Alabama","35294","United States",{"type":75,"coordinates":76},"Point",[77,78],-86.80249,33.52066,{"lat":78,"lon":77},{"type":57,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Pankaj Arora, MD","Associate Professor, Division of Cardiovasular Disease, Department of Medicine","100540754",false,"NCT06320951","VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway","Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway","VITAL-IMPACT","Inclusion Criteria:\n\n* Adults: Age more than or equal to 18 years of age\n* Self-identified race\u002Fethnicity as African-American or Black\n* BMI ≥ 30 kg\u002Fm2\n* HOMA-IR ≥ 2.5\n* Blood pressure: 120-160\u002F80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives)\n* Willing to adhere to study protocol\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)\n* Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia)\n* BP more than 160\u002F100 mmHg or those treated with three or more classes of antihypertensives\n* BMI \\>45 kg\u002Fm2\n* History of diabetes or fasting plasma glucose \\>=126 mg\u002FdL or HbA1C\\>=6.5% or prior treatment with antidiabetics\n* Estimated GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2; albumin-creatinine ratio ≥30 mg\u002Fg\n* Hepatic Transaminase (AST and ALT) levels \\>3x the upper limit of normal\n* Significant psychiatric illness (assessed using validated MINI questionnaire)\n* Anemia (men, Hb\\\u003C13 g\u002FdL; women, Hb \\\u003C12 g\u002FdL)\n* Inability to exercise on a treadmill",true,"ALL","18 Years","80 Years",{"count":95,"type":96},200,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals.",[102,103,104,105,106,107],"Cardiovascular Diseases","Insulin Sensitivity\u002FResistance","Metabolic Disease","Metabolism","Energy Expenditure","Obesity",[106,109,110,111],"Insulin Sensitivity","African Americans","Cyclic Guanosine Monophosphate","NOT_YET_RECRUITING","2026-01-21",{"date":115,"type":116},"2026-01-23","ACTUAL",{"date":118,"type":96},"2026-12-01",{"date":120,"type":96},"2029-04-30",{"name":5,"class":6},1]