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Adiposity and Endothelin Receptor Function (END-RF)

Primary Purpose

Hypertension

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Candesartan
Placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring blood pressure, microdialysis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Candesartan

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2018
Last Updated
July 18, 2022
Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03583866
Brief Title
Adiposity and Endothelin Receptor Function
Acronym
END-RF
Official Title
Adiposity and Endothelin Receptor Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
blood pressure, microdialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candesartan
Arm Type
Experimental
Arm Description
Sub chronic (7 days) Candesartan (16 mg/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Endothelial function will be determined following a seven day treatment of placebo
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Blopress, Atacand, Amias, and Ratacand
Intervention Description
7 days of Candesartan (16mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose capsule, Maltose capsule
Intervention Description
7 days of Placebo
Primary Outcome Measure Information:
Title
Percentage Change in Flow-Mediated Dilation (FMD)
Description
Change in Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.
Time Frame
pre-treatment Baseline and 7 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Harris, PHD, CES
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Links:
URL
http://facebook.com/harrislab
Description
Laboratory of Integrative and Exercise Physiology Website

Learn more about this trial

Adiposity and Endothelin Receptor Function

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