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Sponsors and Collaborators: |
Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00732160 |
Determine the effect of aldosterone on how the body handles glucose (sugar).
Condition | Intervention |
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Diabetes Mellitus |
Drug: Comparison of the effect of aldosterone versus vehicle infusion |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Aldosterone and Glucose Homeostasis |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Aim 1.1: Experimental
Comparison of the effect of aldosterone versus vehicle infusion on insulin secretion
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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.
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Aim 1.2: Active Comparator
Comparison of the effect of aldosterone versus vehicle infusion on insulin sensitivity
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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.
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Determine the effect of aldosterone on glucose metabolism in humans.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
For female subjects, the following conditions must be met:
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
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Exclusion Criteria:
Contact: Loretta Byrne, RN | 615-322-2105 | loretta.byrne@vanderbilt.edu |
Contact: James Luther, MD | 615-343-8701 | james.luther@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Loretta Byrne 615-322-2105 loretta.byrne@vanderbilt.edu |
Principal Investigator: | James M Luther, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( James M. Luther, MD, MSCI ) |
Study ID Numbers: | 080248 |
Study First Received: | August 5, 2008 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00732160 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glucose Insulin |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Glucose Metabolism Disorders Metabolic Disorder Insulin |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |