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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: March 20, 2017
Last verified: March 2017
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
| Official Title: | Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications |
Resource links provided by NLM:
Further study details as provided by Rajesh K. Garg, Brigham and Women's Hospital:
Primary Outcome Measures:
- Change From Baseline in Post-ischemic Dilatation [ Time Frame: Baseline and Week 6 ]Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.
Secondary Outcome Measures:
- Change From Baseline in Para-aminohippurate (PAH) Clearance [ Time Frame: Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion) ]Renal plasma blood flow was determined by clearance of para-aminohippurate (PAH). A loading dose of PAH (8 mg/kg) was given intravenously followed by a 1 hour constant infusion of PAH at a rate of 12 mg/minute (min). Plasma samples were obtained at Baseline and at 50 and 60 minutes. PAH clearance was calculated from the plasma levels and infusion rates and reported in millimeters (mL)/minute (min). A positive change from Baseline indicates improvement.
- Change From Baseline in Markers of Inflammation [ Time Frame: Baseline and Week 6 ]Blood was to be collected and tested for Tumor Necrosis Factor Alpha (TNF-α) and Monocyte Chemotactic Protein-1 (MCP-1), markers of inflammation; However, due to lack of funding, blood samples were not analyzed and data for levels of inflammation markers were not collected.
- Change From Baseline in Insulin Sensitivity Index (ISI) [ Time Frame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes) ]Insulin sensitivity was measured using the 75 gram (G) glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 milliliters (mL) of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. Insulin sensitivity index was calculated by Matsuda and Defronzo's formula using the values obtained. A positive change from Baseline (increase in insulin sensitivity) indicates improvement.
- Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes) ]Insulin resistance was measured using the 75 G glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 mL of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. HOMA-IR was calculated using the Insulin and glucose levels obtained. A negative change (decrease in insulin resistance) indicates improvement.
| Enrollment: | 38 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Spironolactone |
Drug: Spironolactone
50 mg once daily for 6 weeks.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo-matching spironolactone once daily for 6 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-70 years
- Good health as evidenced by history and physical exam
- Body Mass Index (BMI): >30 kg/m2 and <45 kg/m2
Exclusion criteria:
- Medical illnesses other than treated hypothyroidism
- Blood Pressure (BP) >135/85 or systolic BP <90 mm Hg
- Hepatic disease (transaminase > 3 times normal)
- Renal impairment (Creatinine clearance <60 ml/min)
- Baseline serum Potassium (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
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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
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 |
| Results First Received: | January 29, 2017 |
| Last Updated: | March 20, 2017 |
Keywords provided by Rajesh K. Garg, Brigham and Women's Hospital:
|
Obesity Insulin resistance Mineralocorticoid receptor |
Additional relevant MeSH terms:
|
Obesity Insulin Resistance Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Spironolactone Mineralocorticoids Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Hormones |
ClinicalTrials.gov processed this record on August 17, 2017