Cardiovascular Effects of Metformin on Obesity

NCT ID: NCT01910246

Last Updated: 2018-12-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-10-31

Brief Summary

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.

Conditions

Insulin Resistance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin, Insulin Resistance, Cardiac Function,

Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Interventions

Metformin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen G Ordovas, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

David Saloner, PhD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

UCSF, Radiology and Biomedical Imaging

San Francisco, California, United States

Countries

United States

Other Identifiers

Cardiac MRI Metformin

Identifier Type: -

Identifier Source: secondary_id

Metformin Cardiac MRI

Identifier Type: OTHER

Identifier Source: secondary_id

MetforminMRI

Identifier Type: -

Identifier Source: org_study_id