Aldosterone and Glucose Homeostasis

February 21, 2017 updated by: James Matt Luther, Vanderbilt University
Determine the effect of aldosterone on how the body handles glucose (sugar).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Determine the effect of aldosterone on glucose metabolism in humans.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Secretion
Time Frame: 3 hours
Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 080248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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