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Adiposity and Endothelin Receptor Function (END-RF)

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ClinicalTrials.gov Identifier: NCT03583866
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryan Harris, Augusta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan Drug: Placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Adiposity and Endothelin Receptor Function
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Candesartan
Sub chronic (7 days) Candesartan (16 mg/day)
 Drug: Candesartan
7 days of Candesartan (16mg/day)
Other Name: Blopress, Atacand, Amias, and Ratacand
Placebo Comparator: Placebo
Endothelial function will be determined following a seven day treatment of placebo
 Drug: Placebo
7 days of Placebo
Other Name: Lactose capsule, Maltose capsule


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change in Flow-Mediated Dilation (FMD) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583866


Contacts
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Contact: Ryan Harris, PhD, CES 706-721-5998 ryharris@augusta.edu
Contact: Jacob Looney, BS 706-721-5483 jlooney@augusta.edu

Locations
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United States, Georgia
Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology Recruiting
Augusta, Georgia, United States, 30912
Contact: Jacob Looney, BS    706-721-5483    jlooney@augusta.edu   
Sponsors and Collaborators
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ryan Harris, PHD, CES Augusta University
More Information
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Additional Information:

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Responsible Party: Ryan Harris, Assistant Professor, Augusta University
ClinicalTrials.gov Identifier: NCT03583866    
Other Study ID Numbers: 1148277
5P01HL069999 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Harris, Augusta University:
blood pressure
microdialysis
Additional relevant MeSH terms:
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Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Candesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action