Aldosterone and the Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01103245
First received: April 12, 2010
Last updated: August 4, 2011
Last verified: August 2011

April 12, 2010
August 4, 2011
March 2010
January 2012   (final data collection date for primary outcome measure)
Plasma glucose and insulin concentrations [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01103245 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Aldosterone and the Metabolic Syndrome
Aldosterone and the Metabolic Syndrome: Renin Inhibition Versus Mineralocorticoid Receptor (MR) Antagonism

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin secretion in humans.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Metabolic Diseases
  • Diabetes Mellitus
  • Endocrine System Diseases
  • Glucose Metabolism Disorders
  • Drug: Renin-Angiotensin-Aldosterone System (RAAS) Activation
    Subjects will be receive a dose of Hydrochlorothiazide (HCTZ) for 12 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
    Other Name: HCTZ, Professional Compounding Centers of America (PCCA)
  • Drug: Administration of Aliskiren, Spironolactone, or Placebo
    Subjects will be receive a dose of Aliskiren, Spironolactone, or placebo for 4 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
    Other Names:
    • Aliskiren (ALI)- brand name: Tekturna - company: Novartis AG
    • Spironolactone (SPL)- generic brand from PCCA
  • Drug: Increased Dose, Combination, or Placebo
    Subjects will be receive either an increased dose of the present medication (Aliskiren or Spironolactone) or a combination of the two or a placebo for 4 weeks and be given a calculated diet during the last 5 days of this period. Serum potassium levels, urine samples, and blood levels of insulin secretion will be measured.
    Other Names:
    • Aliskiren (ALI)- brand name: Tekturna - company: Novartis AG
    • Spironolactone (SPL)- generic brand from PCCA
  • Placebo Comparator: Renin-Angiotensin Aldosterone Activation
    Renin-Angiotensin-Aldosterone System (RAAS) Activation
    Intervention: Drug: Renin-Angiotensin-Aldosterone System (RAAS) Activation
  • Active Comparator: Aliskiren, Spironolactone, or Placebo
    Determination of effects of MR antagonism or renin inhibition.
    Intervention: Drug: Administration of Aliskiren, Spironolactone, or Placebo
  • Active Comparator: Increased Dose, Combination, or Placebo
    Determination of effects of MR antagonism and/or renin inhibition.
    Intervention: Drug: Increased Dose, Combination, or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
168
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects meeting all of the following conditions will be included in the study:

    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.
    3. A seated or supine systolic blood pressure greater than 130/85 on three separate measurements at least 15 minutes apart
    4. Metabolic Syndrome as defined by the presence of > 3 of the following:

      1. Hypertension as characterized by having Systolic Blood Pressure > 140 mm Hg and Diastolic Blood Pressure > 90 mm Hg.
      2. Impaired Glucose Tolerance (Fasting Plasma Glucose > 100 mg/dL)
      3. Increased triglyceride level > 150mg/dL
      4. Decreased levels of High-Density Lipoprotein (HDL) cholesterol

        1. For males, less than 30 mg/dL
        2. For females, less than 40 mg/dL
      5. Waist circumference

        1. For males, greater than 40 inches.
        2. For females, greater than 35 inches.

Exclusion Criteria:

  • Subjects presenting with any of the following will not be included in the study:

    1. Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medication
    2. Use of hormone replacement therapy
    3. Statin therapy
    4. Pregnancy
    5. Breast-feeding
    6. Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure [Left Ventricular (LV) hypertrophy acceptable], deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
    7. Treatment with anticoagulants
    8. History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack
    9. History or presence of immunological or hematological disorders
    10. Diagnosis of asthma requiring use of inhaled beta agonist >1 time per week
    11. Clinically significant gastrointestinal impairment that could interfere with drug absorption
    12. Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >1.5 x upper limit of normal range]
    13. 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:

      eGFR (ml/min/1.73m2)=175 • Scr-1.154 • age-0.203 • (1.212 if black) • (0.742 if female)

    14. Hematocrit <35%
    15. 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
    16. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
    17. Treatment with lithium salts
    18. History of alcohol or drug abuse
    19. Treatment with any investigational drug in the 1 month preceding the study
    20. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
    21. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
    22. Screening plasma potassium <3.2 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia
Both
18 Years to 70 Years
No
Contact: Loretta Byrne, RN 615-322-2105 loretta.byrne@vanderbilt.edu
Contact: James Luther, MD 615-343-8701 james.luther@vanderbilt.edu
United States
 
NCT01103245
091072, 09CRP2261428
Yes
James M. Luther, MD, MSCI, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: James M Luther, MD Vanderbilt University
Vanderbilt University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP