Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
|ClinicalTrials.gov Identifier: NCT01406015|
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance||Drug: Spironolactone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Active Comparator: Spironolactone||
50 mg once daily for 6 weeks.
|Placebo Comparator: 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.
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|