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
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