Adiposity and Endothelin Receptor Function

Early Phase 1

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Candesartan

• Registration Number: NCT03583866
• Lead Sponsor: Augusta University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Endothelial function will be determined following a seven day treatment of placebo
Candesartan	Candesartan	Sub chronic (7 days) Candesartan (16 mg/day)

Primary Outcome Measures

Name	Time	Method
Percentage Change in Flow-Mediated Dilation (FMD)	pre-treatment Baseline and 7 days post-treatment	Change in Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.

Trial Locations

Locations (1)

Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology; 🇺🇸 Augusta, Georgia, United States