Cardiovascular Effects of Metformin on Obesity
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Insulin Resistance |
| Intervention | Drug: Metformin |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Responsible Party | University of California, San Francisco |
| ClinicalTrials.gov Identifier | NCT01910246 |
| First Received | April 22, 2013 |
| Last Updated | October 15, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 22, 2013 |
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| Last Updated Date | October 15, 2013 |
| Start Date | July 2014 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Left Ventricular Circumferential Strain change after a six-month course of Metformin. [Time Frame: 6 months] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Cardiovascular Effects of Metformin on Obesity |
|---|---|
| Official Title | Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Insulin Resistance |
| Intervention | Drug: Metformin |
| Study Arm (s) | Experimental: Metformin, Insulin Resistance, Cardiac Function, Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 24 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2015 |
| Eligibility 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 |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Karen G Ordovas, MD 415-443-9382 Karen.Ordovas@ucsf.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01910246 |
|---|---|
| Other Study ID Numbers | MetforminMRI |
| Has Data Monitoring Committee | No |
| Information Provided By | University of California, San Francisco |
| Study Sponsor | University of California, San Francisco |
| Collaborators | Department of Veterans Affairs |
| Investigators | Principal Investigator: Karen G Ordovas, MD, MAS University of California, San FranciscoStudy Director: David Saloner, PhD University of California, San Francisco |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| UCSF, Radiology and Biomedical Imaging | San Francisco, California, United States, 94143 Not yet recruiting |
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