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

July 26, 2011
August 12, 2013
February 2009
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01406015 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Obesity
  • Insulin Resistance
  • Drug: Spironolactone
    50 mg daily for 6 weeks
  • Drug: Placebo
    Placebo once daily for 6 weeks
  • Active Comparator: Spironolactone
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01406015
2009P-000311
No
Rajesh K. Garg, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Not Provided
Brigham and Women's Hospital
August 2013

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