protocolSection identificationModule nctId: NCT06320951, orgStudyIdInfo id: 300012681, secondaryIdInfos id: Pending, type: OTHER, domain: Pending, briefTitle: VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway, acronym: VITAL-IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cardiovascular Diseases, conditions: Insulin Sensitivity/Resistance, conditions: Metabolic Disease, conditions: Metabolism, conditions: Energy Expenditure, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Vericiguat 10 MG, interventions name: Placebo, interventions name: Insulin Sensitivity Test, interventions name: Resting Energy and Exercise Energy Expenditure Assessment, interventions name: White Adipose Tissue Biopsy, interventions name: MRI-PET Scan for Brown Adipose Tissue Volume Assessment, outcomesModule primaryOutcomes measure: Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance., primaryOutcomes measure: Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in BAT volume after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in BAT activity after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance., secondaryOutcomes measure: Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False