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Completed

NCT Number: NCT01406015

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

50 mg once daily for 6 weeks.

Placebo

Drug

Placebo-matching spironolactone once daily for 6 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 29, 2011
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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