Status:
WITHDRAWN
Cardiovascular Effects of Metformin on Obesity
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Insulin Resistance
Eligibility:
All Genders
12-17 years
Phase:
PHASE4
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 cardiovascu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01910246
Start Date
April 1 2015
End Date
October 1 2016
Last Update
December 11 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF, Radiology and Biomedical Imaging
San Francisco, California, United States, 94143