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Cardiovascular Effects of Metformin on Obesity

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Insulin Resistance

Intervention: Metformin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Karen G Ordovas, MD, MAS, Principal Investigator, Affiliation: University of California, San Francisco
David Saloner, PhD, Study Director, Affiliation: University of California, San Francisco

Overall contact:
Karen G Ordovas, MD, Phone: 415-443-9382, Email: Karen.Ordovas@ucsf.edu

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.

Clinical Details

Official title: Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Left Ventricular Circumferential Strain change after a six-month course of Metformin.

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Karen G Ordovas, MD, Phone: 415-443-9382, Email: Karen.Ordovas@ucsf.edu

UCSF, Radiology and Biomedical Imaging, San Francisco, California 94143, United States; Not yet recruiting
Additional Information

Starting date: April 2015
Last updated: March 4, 2015

Page last updated: August 23, 2015

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