Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01406015 |
Recruitment Status :
Completed
First Posted : July 29, 2011
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Insulin Resistance | Drug: Spironolactone Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
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. |
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406015
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Responsible Party: | Rajesh K. Garg, Associate Physician, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT01406015 |
Other Study ID Numbers: |
2009P-000311 |
First Posted: | July 29, 2011 Key Record Dates |
Results First Posted: | April 28, 2017 |
Last Update Posted: | April 28, 2017 |
Last Verified: | March 2017 |
Obesity Insulin resistance Mineralocorticoid receptor |
Obesity Insulin Resistance Overnutrition Nutrition Disorders Overweight Body Weight Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents |