Cardiovascular Effects of Metformin on Obesity

NCT01910246 | Withdrawn Phase 4

• 3 other identifiers: MetforminMRICardiac MRI MetforminMetformin Cardiac MRI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

Metformin; Insulin Resistance; Cardiac Function

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Metformin, Insulin Resistance, Cardiac Function,

EXPERIMENTAL

Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.

Drug: Metformin

Interventions

Metformin DRUG

Metformin, Insulin Resistance, Cardiac Function,

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

UCSF, Radiology and Biomedical Imaging

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Karen G Ordovas, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• David Saloner, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: July 29, 2013
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

US (1)