Cardiovascular Effects of Metformin on Obesity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 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: August 15, 2014
Last verified: August 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ 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.


Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Primary Completion Date: June 2015 (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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910246

Contacts
Contact: Karen G Ordovas, MD 415-443-9382 Karen.Ordovas@ucsf.edu
Contact: David Saloner, PhD 415-750-2238 David.Saloner@ucsf.edu

Locations
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
Investigators
Principal Investigator: Karen G Ordovas, MD, MAS University of California, San Francisco
Study Director: David Saloner, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01910246     History of Changes
Other Study ID Numbers: MetforminMRI, Cardiac MRI Metformin, Metformin Cardiac MRI
Study First Received: April 22, 2013
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014