Clinical trial

VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway

Opening soon · Phase 2 · 1 countries · Registry ID NCT06320951

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersAccepted

ConditionCardiovascular Diseases, Insulin Sensitivity/Resistance, Metabolic Disease, Metabolism, Energy Expenditure, Obesity

Full registry criteria

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

Treatments and study arms

Vericiguat 10 MG

Drug

The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.

Placebo

Other

The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.

Insulin Sensitivity Test

Other

An assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions.

Resting Energy and Exercise Energy Expenditure Assessment

Other

Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.

White Adipose Tissue Biopsy

Other

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.

MRI-PET Scan for Brown Adipose Tissue Volume Assessment

Other

Participants who consent to participate in the exploratory aim will undergo PET/MR to BAT volume at baseline and after 12 weeks of pharmacological interventions.

Primary outcomes

Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance.12 weeks

The difference in change in insulin sensitivity between baseline and post-intervention between two arms.

Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance.12 weeks

The difference in change in REE between baseline and post-intervention between two arms.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States

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