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
Sponsor:
Collaborators:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00732160
First received: August 5, 2008
Last updated: March 21, 2011
Last verified: March 2011
  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:

  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 by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014