Insulin Resistance
Conditions
Keywords
Metformin, Insulin Resistance, Cardiac Function
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.
Interventions
DRUGMetformin
Sponsors
US Department of Veterans Affairs
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed