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Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

This study is currently recruiting participants.
Verified October 2012 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Rajesh K. Garg, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01406015
First received: July 26, 2011
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.


Condition Intervention
Obesity
Insulin Resistance
 Drug: Spironolactone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Brachial artery vascular reactivity [ Time Frame: 6 weeks after respective treatments ] [ Designated as safety issue: No ]
    Change in brachial artery vasodilatation in response to ischemia will be compared between treatment and placebo groups.


Secondary Outcome Measures:
  • Renal plasma flow [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in renal plasma blood flow from baseline will be compared between the treatment and placebo groups.

  • Inflammatory markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    TNF alpha and MCP-1 will be measured as markers of inflammation. Changes in TNF alpha and MCP-1 from baseline will be compared between the treatment and placebo groups.

  • Insulin resistance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in insulin resistance from baseline will be compared between the treatment and placebo groups.


Estimated Enrollment: 35
Study Start Date: February 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spironolactone Drug: Spironolactone
50 mg daily for 6 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo once daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 years
  2. Good health as evidenced by history and physical exam
  3. BMI: >30 kg/m2 and <45 kg/m2

Exclusion criteria:

  1. Medical illnesses other than treated hypothyroidism
  2. BP >135/85 or systolic BP <90 mm Hg
  3. Hepatic disease (transaminase > 3 times normal)
  4. Renal impairment (Creatinine clearance <60 ml/min)
  5. Baseline serum K >5.0 mmol/L
  6. History of drug or alcohol abuse
  7. Allergies to spironolactone
  8. Participation in any other concurrent clinical trial
  9. Women using oral contraceptives within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406015

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Maria Baimas-George, BA     617-525-7357     mbaimas-george@partners.org    
Principal Investigator: Rajesh K Garg, MD            
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Rajesh K. Garg, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01406015     History of Changes
Other Study ID Numbers: 2009P-000311
Study First Received: July 26, 2011
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Obesity
Insulin resistance
Mineralocorticoid receptor

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mineralocorticoids
 Spironolactone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Aldosterone Antagonists
Hormone Antagonists
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013