Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
Completed · Phase 4 · Has a placebo group
Conditions studied: Metabolic Syndrome
In brief
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.
Key facts
- Study ID
- NCT02034435
- Run by
- Vanderbilt University Medical Center
- People needed
- 44
- Starts
- 2013-10-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2021-01-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Increased triglyceride level > 150mg/dL (1.7mmol/L)
- Decreased levels of HDL cholesterol (For males, less than 40 mg/dL; For females, less than 50 mg/dL)
- Waist circumference (For males, greater than 40 inches; For females, greater than 35 inches)
You may not qualify if…
- 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
- Use of hormone replacement therapy
- Breast-feeding
- Treatment with anticoagulants
- History of serious neurologic disease
- History or presence of immunological or hematological disorders
- Diagnosis of asthma requiring use of inhaled beta agonist
- Clinically significant gastrointestinal impairment
- Impaired hepatic function
- Hematocrit <35%
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
- Treatment with chronic systemic glucocorticoid therapy
- Treatment with lithium salts
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding
- Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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