Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

March 20, 2017 updated by: Rajesh K. Garg, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo-matching spironolactone once daily for 6 weeks.
Active Comparator: Spironolactone
Drug: Spironolactone
50 mg once daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)
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.
Baseline and Week 6
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.
Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)
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.
Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P-000311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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