Cardiovascular Effects of Metformin on Obesity

Insulin Resistance Clinical Trial

Official title:

Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01910246
• Other study ID #: MetforminMRI
• Secondary ID: Cardiac MRI Metf
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
United States	UCSF, Radiology and Biomedical Imaging	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Circumferential Strain change after a six-month course of Metformin.	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.	6 months