Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2015-04-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin, Insulin Resistance, Cardiac Function,
Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals.
Metformin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
12 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen G Ordovas, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
David Saloner, PhD
Role: STUDY_DIRECTOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSF, Radiology and Biomedical Imaging
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Cardiac MRI Metformin
Identifier Type: -
Identifier Source: secondary_id
Metformin Cardiac MRI
Identifier Type: OTHER
Identifier Source: secondary_id
MetforminMRI
Identifier Type: -
Identifier Source: org_study_id