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Cardiovascular Effects of Metformin on Obesity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by University of California, San Francisco.
Recruitment status was:  Not yet recruiting
VA Office of Research and Development
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: April 22, 2013
Last updated: March 4, 2015
Last verified: March 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 Intervention Phase
Insulin Resistance
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: April 2015
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin, Insulin Resistance, Cardiac Function,
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
Drug: Metformin


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01910246

Contact: Karen G Ordovas, MD 415-443-9382
Contact: David Saloner, PhD 415-750-2238

United States, California
UCSF, Radiology and Biomedical Imaging Not yet recruiting
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
VA Office of Research and Development
Principal Investigator: Karen G Ordovas, MD, MAS University of California, San Francisco
Study Director: David Saloner, PhD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco Identifier: NCT01910246     History of Changes
Other Study ID Numbers: MetforminMRI
Cardiac MRI Metformin
Metformin Cardiac MRI ( Other Identifier: UCSF )
Study First Received: April 22, 2013
Last Updated: March 4, 2015

Keywords provided by University of California, San Francisco:
Insulin Resistance
Cardiac Function

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017