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Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406015
First Posted: July 29, 2011
Last Update Posted: April 28, 2017
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.
Information provided by (Responsible Party):
Rajesh K. Garg, Brigham and Women's Hospital
July 26, 2011
July 29, 2011
January 29, 2017
April 28, 2017
April 28, 2017
February 2009
August 2013   (Final data collection date for primary outcome measure)
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.
Brachial artery vascular reactivity [ Time Frame: 6 weeks after respective treatments ]
Change in brachial artery vasodilatation in response to ischemia will be compared between treatment and placebo groups.
Complete list of historical versions of study NCT01406015 on ClinicalTrials.gov Archive Site
  • 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.
  • Renal plasma flow [ Time Frame: 6 weeks ]
    Change in renal plasma blood flow from baseline will be compared between the treatment and placebo groups.
  • Inflammatory markers [ Time Frame: 6 weeks ]
    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.
  • Insulin resistance [ Time Frame: 6 weeks ]
    Change in insulin resistance from baseline will be compared between the treatment and placebo groups.
Not Provided
Not Provided
 
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Obesity
  • Insulin Resistance
  • Drug: Spironolactone
    50 mg once daily for 6 weeks.
  • Drug: Placebo
    Placebo-matching spironolactone once daily for 6 weeks.
  • Active Comparator: Spironolactone
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-70 years
  2. Good health as evidenced by history and physical exam
  3. Body Mass Index (BMI): >30 kg/m2 and <45 kg/m2

Exclusion criteria:

  1. Medical illnesses other than treated hypothyroidism
  2. Blood Pressure (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 Potassium (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01406015
2009P-000311
No
Not Provided
Not Provided
Rajesh K. Garg, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Not Provided
Brigham and Women's Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP