Insulin ResistancePhase 4NCT01910246
Cardiovascular Effects of Metformin on Obesity
A Phase 4 study testing Metformin in people with Insulin Resistance, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF, Radiology and Biomedical Imaging
San Francisco, California, 94143
About this study
Official title: Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction
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
- Being tested
- Metformin
- Keywords
- Metformin, Insulin Resistance, Cardiac Function
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin, Insulin Resistance, Cardiac Function, | Experimental | Metformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startApr 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Karen G Ordovas, MD, MAS, Principal investigator, University of California, San FranciscoDavid Saloner, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910246
- Sponsor's protocol ID
- MetforminMRI
- Other IDs
- Cardiac MRI Metformin, Metformin Cardiac MRI
- Status last verified
- Dec 2018
- First submitted
- 22 Apr 2013
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction
- ClinicalTrials.gov ID
- NCT01910246
- Acronym / sponsor ID
- MetforminMRI
- Conditions
- Insulin Resistance
- Keywords
- Metformin, Insulin Resistance, Cardiac Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin, Insulin Resistance, Cardiac Function, | Experimental | Drug: MetforminMetformin Hydrochloride Tablets will be administered with a start dose of 500mg twice daily with meals. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Patients with known cardiac disease
- Patients with contraindications to metformin as listed below:
- Patients with contraindications to MRI including:
- Pregnancy;
- Patients who could not stay still for 30 minutes within the MRI scanner due to other reasons besides claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Metformin, Insulin Resistance, Cardiac Function, |
Primary outcome
Left Ventricular Circumferential Strain change after a six-month course of Metformin.
Time frame: 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen G Ordovas, MD, MAS principal investigator
University of California, San Francisco
David Saloner, PhD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Insulin Resistance, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Circumferential Strain change after a six-month course of Metformin. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.