N/A
N=38
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Obesity · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT01406015 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Post-ischemic Dilatation — 9.6; 10.2; -1.2; -2.0 percent dilalation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spironolactone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Post-ischemic Dilatation |
9.6; 10.2; -1.2; -2.0 | — |
| SECONDARY Change From Baseline in Para-aminohippurate (PAH) Clearance |
488; 521; -2.3; -5.2 | — |
| SECONDARY Change From Baseline in Markers of Inflammation |
— | — |
| SECONDARY Change From Baseline in Insulin Sensitivity Index (ISI) |
3.7; 4.6; -0.1; -1.1 | — |
| SECONDARY Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
2.7; 3.4; 0.1; 0.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Good health as evidenced by history and physical exam
- Body Mass Index (BMI): >30 kg/m2 and 135/85 or systolic BP 3 times normal)
- Renal impairment (Creatinine clearance 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
Data sourced from ClinicalTrials.gov (NCT01406015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.