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Aldosterone and Glucose Homeostasis
This study is currently recruiting participants.
Verified by Vanderbilt University, August 2009
First Received: August 5, 2008   Last Updated: August 18, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00732160
  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: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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: 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
Aim 1.1: Experimental
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.
Aim 1.2: Active Comparator
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:

  1. Ambulatory subjects, 18 to 70 years of age, inclusive
  2. For female subjects, the following conditions must be met:

    1. postmenopausal status for at least 1 year, or
    2. status-post surgical sterilization, or
    3. 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:

      1. BMI greater than 31 kg/m2
      2. Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medication
      3. Serum triglycerides greater than 150 mg/dL (1.7 mmol/L)
      4. Total cholesterol greater than 200 mg/dL (5.18 mmol/L)
      5. Use of hormone replacement therapy
      6. Statin therapy
      7. A seated or supine systolic blood pressure greater than 130/85 on three separate measurements at least 15 minutes apart
      8. Pregnancy
      9. Breast-feeding
      10. 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
      11. Treatment with anticoagulants
      12. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
      13. History or presence of immunological or hematological disorders
      14. Diagnosis of asthma requiring use of inhaled beta agonist > 1 time per week
      15. Clinically significant gastrointestinal impairment that could interfere with drug absorption
      16. Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >1.5 x upper limit of normal range]
      17. Impaired renal function [estimated glomerular filtration rate (eGFR) of <60ml/min]
      18. Hematocrit <35%
      19. 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
      20. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
      21. Treatment with lithium salts
      22. History of alcohol or drug abuse
      23. Treatment with any investigational drug in the 1 month preceding the study
      24. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
      25. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
      26. 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: Vanderbilt University Medical Center ( James M. Luther, MD, MSCI )
Study ID Numbers: 080248
Study First Received: August 5, 2008
Last Updated: August 18, 2009
ClinicalTrials.gov Identifier: NCT00732160     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Glucose
Insulin

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 26, 2009