nctId: NCT06320951 id: 300012681 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-04-30 date: 2029-04-30 date: 2024-03-20 date: 2024-04-10 name: University of Alabama at Birmingham class: OTHER 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. conditions: Cardiovascular Diseases conditions: Insulin Sensitivity/Resistance conditions: Metabolic Disease conditions: Metabolism conditions: Energy Expenditure conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Vericiguat 10 MG name: Placebo name: Insulin Sensitivity Test name: Resting Energy and Exercise Energy Expenditure Assessment name: White Adipose Tissue Biopsy name: MRI-PET Scan for Brown Adipose Tissue Volume Assessment measure: Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. measure: Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance. measure: Change in BAT volume after vericiguat in Black obese individuals with insulin resistance. measure: Change in BAT activity after vericiguat in Black obese individuals with insulin resistance. measure: Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance. measure: Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance. measure: Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance. measure: Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance. measure: Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance. measure: Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 hasResults: False