Adiposity and Endothelin Receptor Function

NCT03583866 | Active Not Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 11482775P01HL069999
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

blood pressure; microdialysis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Candesartan

EXPERIMENTAL

Sub chronic (7 days) Candesartan (16 mg/day)

Drug: Candesartan

Placebo

PLACEBO COMPARATOR

Endothelial function will be determined following a seven day treatment of placebo

Drug: Placebo

Interventions

Candesartan DRUG

7 days of Candesartan (16mg/day)

Also known as: Blopress, Atacand, Amias, and Ratacand

Candesartan

Placebo DRUG

7 days of Placebo

Also known as: Lactose capsule, Maltose capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• If you are an adult between the ages of 18-40 year old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Augusta University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology

Augusta, Georgia, 30912, United States

Location

Related Links

• Laboratory of Integrative and Exercise Physiology Website

MeSH Terms

Conditions

Hypertension

Interventions

candesartan; candesartan cilexetil; Maltose

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Ryan Harris, PHD, CES

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 12, 2018
• Study Start: May 21, 2018
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

US (1)