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Adiposity and Endothelin Receptor Function (END-RF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583866
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : July 20, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryan Harris, Augusta University

Tracking Information
First Submitted Date  ICMJE June 27, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 20, 2022
Actual Study Start Date  ICMJE May 21, 2018
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adiposity and Endothelin Receptor Function
Official Title  ICMJE Adiposity and Endothelin Receptor Function
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Candesartan
    7 days of Candesartan (16mg/day)
    Other Name: Blopress, Atacand, Amias, and Ratacand
  • Drug: Placebo
    7 days of Placebo
    Other Name: Lactose capsule, Maltose capsule
Study Arms  ICMJE
  • Experimental: Candesartan
    Sub chronic (7 days) Candesartan (16 mg/day)
    Intervention: Drug: Candesartan
  • Placebo Comparator: Placebo
    Endothelial function will be determined following a seven day treatment of placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 18, 2022)
25
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
200
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583866
Other Study ID Numbers  ICMJE 1148277
5P01HL069999 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ryan Harris, Augusta University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Augusta University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Ryan Harris, PHD, CES Augusta University
PRS Account Augusta University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP