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NCT03583866 Clinical Trial

Adiposity and Endothelin Receptor Function

Hypertension Clinical Trial

— END-RF  

Official title:
Adiposity and Endothelin Receptor Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03583866
Other study ID # 1148277
Secondary ID 5P01HL069999
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date May 21, 2018
Est. completion date January 2026

Study information
Verified date January 2024
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Elevated levels of ET-1 have been implicated in cardiovascular disease and some forms of hypertension. Due to the strong, positive correlation between obesity and hypertension, the present study will explore the contribution of adiposity in ETB receptor function and aim to elucidate if ETB receptor dysfunction is a major contributor to hypertension in obesity.

Description:

The proposed study is designed to investigate the influence of adiposity on ETB receptor function and subsequent vascular responses. The combination of ET-1, ET-3, and the respective ETA and ETB receptor antagonists will be used to provide insight into the mechanisms of ETB receptor dysfunction in the presence of adiposity. Previous studies have revealed elevations in circulating ET-1 in obese individuals; therefore, we predict that obese subjects will exhibit 1) ETB receptor dysfuncton compared to lean subjects and 2) an improvement in ETB receptor dysfunction following treatment with Candesartan.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date January 2026
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: • If you are an adult between the ages of 18-40 year old Exclusion Criteria: - Evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease - Evidence of pregnancy - Using medications that affect vascular tone (i.e., nitrates, etc.) - Use of any anticoagulants (i.e. aspirin) - Anemia - If you are postmenopausal - If you have uncontrolled hypertension (treated resting SBP >140 mm Hg or DBP >90 mm Hg)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Candesartan
7 days of Candesartan (16mg/day)
• Placebo
7 days of Placebo

Locations
Country Name City State
United States Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology Augusta Georgia

Sponsors (2)
Lead Sponsor Collaborator
Augusta University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage Change in Flow-Mediated Dilation (FMD) Change in Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment. pre-treatment Baseline and 7 days post-treatment
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