Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

This study has been completed.
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: August 12, 2013
Last verified: August 2013
  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:


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.


Enrollment: 32
Study Start Date: February 2009
Primary Completion Date: August 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
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: NCT01406015

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 12, 2013
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
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014