CompletedPhase 4

Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism

United States44 participantsStarted 2013-10

Plain-language summary

Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion. Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ambulatory subjects, 18 to 70 years of age, inclusive
✓. For female subjects, the following conditions must be met:
✓. postmenopausal status for at least 1 year, or
✓. status-post surgical sterilization, or
✓. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.
✓. Metabolic Syndrome as defined by the presence of \> 3 of the following:
✓. Systolic Blood Pressure \> 130 mm Hg OR Diastolic Blood Pressure \> 85 mm Hg.
✓. Glucose Intolerance (Fasting Plasma Glucose ≥ 100 mg/dL)

Exclusion criteria

✕. type 1 Diabetes
✕. Type II Diabetes
✕. Impaired renal function
✕. Prior allergies to medications used in the study protocol
✕. Screening plasma potassium \>5.5 mmol/L or sodium \<135 mmol/L
✕. Cardiovascular disease

What they're measuring

Insulin Secretion

Timeframe: After 8 days of diet or drug

Insulin Sensitivity

Timeframe: after 8 days of diet or medication

Trial details

NCT IDNCT02034435

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2020-12-06

View on ClinicalTrials.gov More Metabolic Syndrome trials