We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aldosterone and Glucose Homeostasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732160
First Posted: August 11, 2008
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Matt Luther, Vanderbilt University
  Purpose
Determine the effect of aldosterone on how the body handles glucose (sugar).

Condition Intervention
Diabetes Mellitus Drug: Aldosterone infusion (A) Drug: Vehicle Infusion (V) Other: High Sodium Diet (HS) Other: Low Sodium Diet (LS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Aldosterone and Glucose Homeostasis

Resource links provided by NLM:


Further study details as provided by James Matt Luther, Vanderbilt University:

Primary Outcome Measures:
  • Insulin Secretion [ Time Frame: 3 hours ]
    Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)


Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 3 hours ]
    Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.


Enrollment: 34
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
Experimental: HS-V/A; LS-V/A
High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion
Drug: Aldosterone infusion (A)
Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
Other Name: placebo
Drug: Vehicle Infusion (V)
Vehicle infusion for 12.5 hours
Other: High Sodium Diet (HS)
160 mmol/d sodium diet for 7 days
Other: Low Sodium Diet (LS)
20 mmol/d sodium diet for 9 days
Experimental: HS-A/V; LS-A/V
High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion
Drug: Aldosterone infusion (A)
Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
Other Name: placebo
Drug: Vehicle Infusion (V)
Vehicle infusion for 12.5 hours
Other: High Sodium Diet (HS)
160 mmol/d sodium diet for 7 days
Other: Low Sodium Diet (LS)
20 mmol/d sodium diet for 9 days
Experimental: LS-V/A; HS-V/A
Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion
Drug: Aldosterone infusion (A)
Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
Other Name: placebo
Drug: Vehicle Infusion (V)
Vehicle infusion for 12.5 hours
Other: High Sodium Diet (HS)
160 mmol/d sodium diet for 7 days
Other: Low Sodium Diet (LS)
20 mmol/d sodium diet for 9 days
Experimental: LS-A/V; HS-A/V
Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion
Drug: Aldosterone infusion (A)
Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
Other Name: placebo
Drug: Vehicle Infusion (V)
Vehicle infusion for 12.5 hours
Other: High Sodium Diet (HS)
160 mmol/d sodium diet for 7 days
Other: Low Sodium Diet (LS)
20 mmol/d sodium diet for 9 days

Detailed Description:
Determine the effect of aldosterone on glucose metabolism in humans.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732160


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: James M Luther, MD Vanderbilt University Medical Center
  More Information

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
First Submitted: August 5, 2008
First Posted: August 11, 2008
Results First Submitted: May 8, 2015
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: February 2017

Keywords provided by James Matt Luther, Vanderbilt University:
Glucose
Insulin

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