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Adiposity and Endothelin Receptor Function (END-RF)

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Augusta University

Status and phase

Active, not recruiting
Early Phase 1

Conditions

Hypertension

Treatments

Drug: Candesartan
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03583866
1148277
5P01HL069999 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

25 participants in 2 patient groups, including a placebo group

Candesartan
Experimental group
Description:
Sub chronic (7 days) Candesartan (16 mg/day)
Treatment:
Drug: Candesartan
Placebo
Placebo Comparator group
Description:
Endothelial function will be determined following a seven day treatment of placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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