Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
This study has been completed.
Sponsor:
Brigham and Women's Hospital
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
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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:
MedlinePlus related topics:
Diabetes Medicines
Drug Information available for:
Spironolactone
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.
| 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:
- 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
Contacts and Locations
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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
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 Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Overnutrition Overweight Signs and Symptoms Mineralocorticoids Spironolactone |
Cardiovascular Agents Diuretics Diuretics, Potassium Sparing Hormone Antagonists Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Mineralocorticoid Receptor Antagonists Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015