Aldosterone and Glucose Homeostasis

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
James Matt Luther, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00732160
First received: August 5, 2008
Last updated: July 8, 2014
Last verified: July 2014
  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 ]

Enrollment: 68
Study Start Date: September 2008
Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aldosterone infusion
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.
Placebo Comparator: Vehicle infusion 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:   No
Criteria

Inclusion Criteria:

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

    a postmenopausal status for at least 1 year, or b status-post surgical sterilization, or c 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

  3. Metabolic Syndrome as defined by the presence of > 3 of the following:

a Systolic Blood Pressure > 130 mm Hg OR Diastolic Blood Pressure > 85 mm Hg. b Glucose Intolerance (Fasting Plasma Glucose > 100 mg/dL) c Increased triglyceride level > 150mg/dL (1.7mmol/L) d Decreased levels of HDL cholesterol For males, less than 40 mg/dL For females, less than 50 mg/dL e Waist circumference For males, greater than 40 inches (102 cm) For females, greater than 35 inches (89 cm).

Exclusion Criteria:

  1. Previously diagnosed Type I Diabetes , or the use of anti-diabetic medication. Subjects with type II diabetes not on medication will be allowed to participate if fasting blood glucose is <200mg/dL.
  2. Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride).
  3. Screening plasma potassium <3.5 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia
  4. Use of hormone replacement therapy
  5. If on statin therapy for hypercholesterolemia, a change in dose within the past 6 months.
  6. Breast-feeding
  7. Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, 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
  8. Treatment with anticoagulants
  9. History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack
  10. History or presence of immunological or hematological disorders
  11. Diagnosis of asthma requiring use of inhaled beta agonist >1 time per week
  12. Clinically significant gastrointestinal impairment that could interfere with drug absorption
  13. Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >2.0 x upper limit of normal range]
  14. Impaired renal function [estimated glomerular filtration rate (eGFR) of <60ml/min] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years:
  15. eGFR <60 ml/min
  16. Hematocrit <35%
  17. 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
  18. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
  19. Treatment with lithium salts
  20. History of alcohol or drug abuse
  21. Treatment with any investigational drug in the 1 month preceding the study
  22. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
  23. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732160

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
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 Matt Luther, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00732160     History of Changes
Other Study ID Numbers: 080248
Study First Received: August 5, 2008
Last Updated: July 8, 2014
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 August 28, 2014