Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications - Full Text View

Purpose

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.

Condition	Intervention
Obesity Insulin Resistance	Drug: Spironolactone Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Resource links provided by NLM:

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Brachial artery vascular reactivity [ Time Frame: 6 weeks after respective treatments ] [ Designated as safety issue: No ]
Change in brachial artery vasodilatation in response to ischemia will be compared between treatment and placebo groups.

Secondary Outcome Measures:

Renal plasma flow [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change in renal plasma blood flow from baseline will be compared between the treatment and placebo groups.
Inflammatory markers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in insulin resistance from baseline will be compared between the treatment and placebo groups.


Enrollment:	32
Study Start Date:	February 2009
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Spironolactone	Drug: Spironolactone 50 mg daily for 6 weeks
Placebo Comparator: Placebo	Drug: Placebo Placebo once daily for 6 weeks

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-70 years
Good health as evidenced by history and physical exam
BMI: >30 kg/m2 and <45 kg/m2

Exclusion criteria:

Medical illnesses other than treated hypothyroidism
BP >135/85 or systolic BP <90 mm Hg
Hepatic disease (transaminase > 3 times normal)
Renal impairment (Creatinine clearance <60 ml/min)
Baseline serum 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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01406015

Locations


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

Sponsors and Collaborators

Brigham and Women's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.

Garg R, Kneen L, Williams GH, Adler GK. Effect of mineralocorticoid receptor antagonist on insulin resistance and endothelial function in obese subjects. Diabetes Obes Metab. 2014 Mar;16(3):268-72. doi: 10.1111/dom.12224. Epub 2013 Oct 31.


Responsible Party:	Rajesh K. Garg, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01406015 History of Changes
Other Study ID Numbers:	2009P-000311
Study First Received:	July 26, 2011
Last Updated:	August 12, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:


Obesity Insulin resistance Mineralocorticoid receptor

Additional relevant MeSH terms:


Obesity Insulin Resistance Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases	Spironolactone Mineralocorticoids Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Hormones

ClinicalTrials.gov processed this record on September 26, 2016