Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Obesity Clinical Trial

Official title:

Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406015
• Other study ID #: 2009P-000311
• Status: Completed
• Phase: N/A
• First received: July 26, 2011
• Last updated: August 12, 2013
• Start date: February 2009

Study information

• Verified date: August 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Spironolactone
50 mg daily for 6 weeks
• Placebo
Placebo once daily for 6 weeks

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery vascular reactivity	Change in brachial artery vasodilatation in response to ischemia will be compared between treatment and placebo groups.	6 weeks after respective treatments	No
Secondary	Renal plasma flow	Change in renal plasma blood flow from baseline will be compared between the treatment and placebo groups.	6 weeks	No
Secondary	Inflammatory markers	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.	6 weeks	No
Secondary	Insulin resistance	Change in insulin resistance from baseline will be compared between the treatment and placebo groups.	6 weeks	No