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History of Changes for Study: NCT03583866
Adiposity and Endothelin Receptor Function (END-RF)
Latest version (submitted July 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 10, 2018 None (earliest Version on record)
2 October 7, 2019 Study Status
3 January 15, 2021 Study Status
4 July 18, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03583866
Submitted Date:  July 10, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1148277
Brief Title: Adiposity and Endothelin Receptor Function (END-RF)
Official Title: Adiposity and Endothelin Receptor Function
Secondary IDs: 5P01HL069999 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Recruiting
Study Start: May 21, 2018
Primary Completion: June 2020 [Anticipated]
Study Completion: June 2021 [Anticipated]
First Submitted: June 27, 2018
First Submitted that
Met QC Criteria:
July 10, 2018
First Posted: July 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 10, 2018
Last Update Posted: July 12, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Augusta University
Responsible Party: Principal Investigator
Investigator: Ryan Harris
Official Title: Assistant Professor
Affiliation: Augusta University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Open or close this module Conditions
Conditions: Hypertension
Keywords: blood pressure
microdialysis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Candesartan
Sub chronic (7 days) Candesartan (16 mg/day)
Drug: Candesartan
7 days of Candesartan (16mg/day)
Other Names:
  • 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 Names:
  • Lactose capsule, Maltose capsule
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 40 Years
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Ryan Harris, PhD, CES
Telephone: 706-721-5998
Email: ryharris@augusta.edu
Central Contact Backup: Jacob Looney, BS
Telephone: 706-721-5483
Email: jlooney@augusta.edu
Study Officials: Ryan Harris, PHD, CES
Principal Investigator
Augusta University
Locations: United States, Georgia
Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
[Recruiting]
Augusta, Georgia, United States, 30912
Contact:Contact: Jacob Looney, BS 706-721-5483 jlooney@augusta.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Laboratory of Integrative and Exercise Physiology Website
Available IPD/Information:

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