Cardiovascular Effects of Metformin on Obesity
|ClinicalTrials.gov Identifier: NCT01910246|
Recruitment Status : Unknown
Verified March 2015 by University of California, San Francisco.
Recruitment status was: Not yet recruiting
First Posted : July 29, 2013
Last Update Posted : March 6, 2015
It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional myocardial contraction, with preserved global cardiac function. Metformin has been shown to decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance, but the mechanism of cardiovascular protection is unknown.
The purpose of this study is to evaluate the reversibility of subclinical cardiovascular abnormalities in obese adolescents with insulin resistance after a six-month course of Metformin. The investigators hypothesized that the beneficial effects of Metformin will be progressive and sustained after six months of therapy.
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Drug: Metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||June 2016|
Experimental: Metformin, Insulin Resistance, Cardiac Function,
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
- Left Ventricular Circumferential Strain change after a six-month course of Metformin. [ Time Frame: 6 months ]Circumferential strain will be measured by cardiac MRI before and after the treatment. Change in circumferential strain (measured as percentage from end-diastolic wall thickness) from baseline is the main outcome of this study. We hypothesize that abnormal baseline circumferential stain will increase and reach normal values after Metformin treatment. We hypothesized that the beneficial effects of Metformin will be progressive and sustained.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910246
|Contact: Karen G Ordovas, MD||415-443-9382||Karen.Ordovas@ucsf.edu|
|Contact: David Saloner, PhD||415-750-2238||David.Saloner@ucsf.edu|
|United States, California|
|UCSF, Radiology and Biomedical Imaging||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Karen G Ordovas, MD, MAS||University of California, San Francisco|
|Study Director:||David Saloner, PhD||University of California, San Francisco|