Obesity Clinical Trial
— VITAL-IMPACTOfficial title:
Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | April 30, 2029 |
Est. primary completion date | April 30, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adults: Age more than or equal to 18 years of age - Self-identified race/ethnicity as African-American or Black - BMI = 30 kg/m2 - HOMA-IR = 2.5 - Blood pressure: 120-160/80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives) - Willing to adhere to study protocol Exclusion Criteria: - 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) - Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia) - BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives - BMI >45 kg/m2 - History of diabetes or fasting plasma glucose >=126 mg/dL or HbA1C>=6.5% or prior treatment with antidiabetics - Estimated GFR < 60 ml/min/1.73 m2; albumin-creatinine ratio =30 mg/g - Hepatic Transaminase (AST and ALT) levels >3x the upper limit of normal - Significant psychiatric illness (assessed using validated MINI questionnaire) - Anemia (men, Hb<13 g/dL; women, Hb <12 g/dL) - Inability to exercise on a treadmill |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. | The difference in change in insulin sensitivity between baseline and post-intervention between two arms. | 12 weeks | |
Primary | Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in REE between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in BAT volume after vericiguat in Black obese individuals with insulin resistance. | The difference in change in BAT volume between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in BAT activity after vericiguat in Black obese individuals with insulin resistance. | The difference in change in BAT activity between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance. | The difference in change in UCP1 gene expression between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in EEE between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in HbA1C between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in BMI between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in TC between baseline and post-intervention between two arms. | 12 weeks | |
Secondary | Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance. | The difference in change in LDL-C between baseline and post-intervention between two arms. | 12 weeks |
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