Phase 4
N=44
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02034435 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Insulin Secretion — 293.1; 234.7; 330.8; 300.4 uU/mL*10min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Low Salt diet plus Placebo tablet (Other); Low Sodium diet plus Salt tablet (Other); Epleronone (Drug); Amlodipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Secretion |
293.1; 234.7; 330.8; 300.4 | — |
| PRIMARY Insulin Sensitivity |
6.6; 6.9; 6.4; 6.3 | — |
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.
Eligibility Criteria
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)
- 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)
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
- 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
Data sourced from ClinicalTrials.gov (NCT02034435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.