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Cardiovascular Effects of Metformin on Obesity

Primary Purpose

Insulin Resistance

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Metformin, Insulin Resistance, Cardiac Function

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF, Radiology and Biomedical Imaging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin, Insulin Resistance, Cardiac Function,

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
December 7, 2018
Sponsor
University of California, San Francisco
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01910246
Brief Title
Cardiovascular Effects of Metformin on Obesity
Official Title
Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Metformin, Insulin Resistance, Cardiac Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin, Insulin Resistance, Cardiac Function,
Arm Type
Experimental
Arm Description
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Left Ventricular Circumferential Strain change after a six-month course of Metformin.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen G Ordovas, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Saloner, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
UCSF, Radiology and Biomedical Imaging
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Effects of Metformin on Obesity

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