Cardiovascular Effects of Metformin on Obesity

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01910246

Collaborator

US Department of Veterans Affairs (U.S. Fed)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Drug: Metformin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin, Insulin Resistance, Cardiac Function, Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.	Drug: Metformin

Arm

Intervention/Treatment

Experimental: Metformin, Insulin Resistance, Cardiac Function,

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

Drug: Metformin

Outcome Measures

Primary Outcome Measures

Left Ventricular Circumferential Strain change after a six-month course of Metformin. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UCSF, Radiology and Biomedical Imaging	San Francisco	California	United States	94143

Sponsors and Collaborators

University of California, San Francisco
US Department of Veterans Affairs

Investigators

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