Cardiovascular Effects of Metformin on Obesity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01910246
First received: April 22, 2013
Last updated: October 15, 2013
Last verified: October 2013

April 22, 2013
October 15, 2013
July 2014
June 2015   (final data collection date for primary outcome measure)
Left Ventricular Circumferential Strain change after a six-month course of Metformin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01910246 on ClinicalTrials.gov Archive Site
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Cardiovascular Effects of Metformin on Obesity
Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Insulin Resistance
Drug: Metformin
Experimental: Metformin, Insulin Resistance, Cardiac Function,
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
Not Provided
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adolescents 12 to 17 years old under clinical care at the UCSF WATCH clinic
  • Body mass index> 95th percentile for age and gender according to the Centers for Disease Control and Prevention 2000 growth charts for the United States
  • Insulin resistant after 6 months of healthy diet and exercise
  • Able to understand the assent form

Exclusion Criteria:

  • Patients with known cardiac disease
  • Patients with contraindications to metformin as listed below:

    • Renal disease or renal (serum creatinine levels ≥1.5 mg/dL for males, and ≥1.4 mg/dL for females;
    • Known hypersensitivity to Metformin;
    • Acute or chronic metabolic acidosis;
  • Patients with contraindications to MRI including:

    • Cardiac pacemaker;
    • Claustrophobia;
    • Metallic foreign body in the eye,
    • Aneurysm clip in the brain
  • Pregnancy;
  • Patients who could not stay still for 30 minutes within the MRI scanner due to other reasons besides claustrophobia
Both
12 Years to 17 Years
No
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
 
NCT01910246
MetforminMRI, Cardiac MRI Metformin, Metformin Cardiac MRI
No
University of California, San Francisco
University of California, San Francisco
Department of Veterans Affairs
Principal Investigator: Karen G Ordovas, MD, MAS University of California, San Francisco
Study Director: David Saloner, PhD University of California, San Francisco
University of California, San Francisco
October 2013

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