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

Tracking Information
First Received Date ^ICMJE	July 26, 2011
Last Updated Date	October 2, 2012
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 28, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01406015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 28, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Official Title ^ICMJE	Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Obesity Insulin Resistance
Intervention ^ICMJE	Drug: Spironolactone 50 mg daily for 6 weeks Drug: Placebo Placebo once daily for 6 weeks
Study Arm (s)	Active Comparator: Spironolactone Intervention: Drug: Spironolactone Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	35
Completion Date	Not Provided
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-70 years Good health as evidenced by history and physical exam BMI: >30 kg/m2 and <45 kg/m2 Exclusion criteria: Medical illnesses other than treated hypothyroidism BP >135/85 or systolic BP <90 mm Hg Hepatic disease (transaminase > 3 times normal) Renal impairment (Creatinine clearance <60 ml/min) Baseline serum K >5.0 mmol/L History of drug or alcohol abuse Allergies to spironolactone Participation in any other concurrent clinical trial Women using oral contraceptives within the last 3 months
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01406015
Other Study ID Numbers ^ICMJE	2009P-000311
Has Data Monitoring Committee	No
Responsible Party	Rajesh K. Garg, Brigham and Women's Hospital
Study Sponsor ^ICMJE	Brigham and Women's Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Brigham and Women's Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top