Aldosterone and Glucose Homeostasis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Vanderbilt University
Collaborators:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00732160
First received: August 5, 2008
Last updated: March 21, 2011
Last verified: March 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Determine the effect of aldosterone on how the body handles glucose (sugar).
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus |
Drug: Comparison of the effect of aldosterone versus vehicle infusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Aldosterone and Glucose Homeostasis |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Plasma glucose and insulin concentrations [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aim 1.1
Comparison of the effect of aldosterone versus vehicle infusion on insulin secretion
|
Drug: Comparison of the effect of aldosterone versus vehicle infusion
36 subjects will receive a calculated diet then a dose of aldosterone or placebo. Blood levels of insulin secretion will be measured.
|
|
Active Comparator: Aim 1.2
Comparison of the effect of aldosterone versus vehicle infusion on insulin sensitivity
|
Drug: Comparison of the effect of aldosterone versus vehicle infusion
24 subjects will be given a controlled diet for 9 days then a dose of aldosterone. Blood will be collected and measured for levels of insulin sensitivity.
|
Detailed Description:
Determine the effect of aldosterone on glucose metabolism in humans.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
-
Exclusion Criteria:
- BMI greater than 31 kg/m2
- Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medication
- Serum triglycerides greater than 150 mg/dL (1.7 mmol/L)
- Total cholesterol greater than 200 mg/dL (5.18 mmol/L)
- Use of hormone replacement therapy
- Statin therapy
- A seated or supine systolic blood pressure greater than 130/85 on three separate measurements at least 15 minutes apart
- Pregnancy
- Breast-feeding
- Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia (atrial fibrillation or ventricular tachycardia), congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- Treatment with anticoagulants
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History or presence of immunological or hematological disorders
- Diagnosis of asthma requiring use of inhaled beta agonist > 1 time per week
- Clinically significant gastrointestinal impairment that could interfere with drug absorption
- Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >1.5 x upper limit of normal range]
- Impaired renal function [estimated glomerular filtration rate (eGFR) of <60ml/min]
- 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 (more than 7 consecutive days in 1 month)
- Treatment with lithium salts
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding the study
- 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
- Potassium less than 3.5mmol/L or use of chronic potassium supplements.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732160
Contacts
| Contact: Loretta Byrne, RN | 615-322-2105 | loretta.byrne@vanderbilt.edu |
| Contact: James Luther, MD | 615-343-8701 | james.luther@vanderbilt.edu |
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Loretta Byrne 615-322-2105 loretta.byrne@vanderbilt.edu | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | James M Luther, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | James M. Luther, MD, MSCI, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00732160 History of Changes |
| Other Study ID Numbers: | 080248 |
| Study First Received: | August 5, 2008 |
| Last Updated: | March 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
Glucose Insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013