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ObesityPhase 2/3NCT00209482

Glaser Obesity Study

A Phase 2/3 study testing glucophage XR in people with Obesity, run by Glaser Pediatric Research Network at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Obesity
What is being tested?
glucophage XR
How many people
76 participants
Where
5 sitesUnited States
Study dates
Oct 2003to Nov 2007
Phase
Phase 2/3
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 13 to 18 years
  • All sexes
  • Child, Adult

Who may be able to join

  • Subjects must be between the ages of 13.00 and 17.99 at week 0 (Baseline).
  • Subjects must have a BMI ≥ 95th percentile for age and gender using the CDC data (see Appendix), but must weigh less than 300 pounds (<136 kilograms) when measured during the initial physical exam at week 0 (Baseline). BMI will be calculated as follows; weight in kilograms  [height in meters]2. This cutoff has been established due to the weight-bearing limits of the table used in performing the DXA scan. Once enrolled, if a subject's weight progresses above 300 pounds, s/he may continue in the study whether it is possible to perform DXA or not.
  • Completion of informed consent/assent process

Who cannot join

  • Known diabetes as defined by the American Diabetes Association criteria
  • Prior drug therapy to treat diabetes or insulin insensitivity, including any form of insulin or insulin analogs; or any oral antidiabetic medication; acarbose, acetohexamide, chlorpropamide, glimepiride, glipizide, glyburide, metformin, pioglitazone, repaglinide, rosiglitazone, tolazamide, tolbutamide or troglitazone.
  • Prior use of drugs to aid in weight loss, including but not limited to: Benzphetamine Hcl, Diethylpropion Hcl, Fenfluramine Hcl, Phendimetrazine Tartrate, Phentermine Hcl, Orlistat, Sibutramine Hcl Monohydrate, Didrex, Tenuate, Pondimin, Bontril-SR, Adipex-P, Fastin, Ionamin, Phentrol, Xenical, Meridia.
  • Subject is currently taking the following medications at the time of the Screening visit: Cimetidine, amiloride, digoxin, furosemide, morphine, nifedipine, procainamide, ranitidine, triamterene, trimethoprim, vancomycin and quinidine, as these medications may increase metformin levels.
  • Subjects will be excluded from the study if they have taken prescription-strength glucocorticoids (by any route) within three months of the screening visit. Topical glucocorticoids are acceptable if their strength is no greater than the equivalent of 1% hydrocortisone cream.
  • History of any syndrome or medical disorder associated with significant obesity, including but not limited to: Prader Willi Syndrome, Bardet-Biedl Syndrome, Cohen Syndrome, Cushing syndrome or disease.
Show all 17Show fewer
  • Prior surgical therapy for obesity
  • Subject to be excluded if s/he has attended a formal weight loss program within 6 months prior to the Screening visit.
  • In the 6 months prior to Screening, subject has consumed alcohol more frequently than twice per week and/or subject has had more than three alcohol-containing beverages in a 24 hour period.
  • Elevated creatinine (> 1.2 mg/dl)
  • Untreated disorders of thyroid function
  • Elevated liver enzymes (Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST]) > 80 (approximately 2 times upper limit of normal)
  • Mobility impairment that prevents full participation in recommended physical activity
  • Other serious medical condition that the Principal Investigator or Lead Site Investigator determines may put the patient at undue risk if enrolled in the study
  • Unable to comply with the protocol in the opinion of the Principal Investigator or the Lead Site Investigator
  • Subjects with child-bearing potential who are unwilling to remain abstinent or use an effective method of birth control
  • Previous pregnancy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Children's Hospital, Boston

    Boston, Massachusetts, 02115

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • University of California, San Francisco

    San Francisco, California, 94143

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Placebo Controlled, Double Blind Trial of Metformin in Obese Adolescents.

This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.

Read the detailed description

America is facing an epidemic of obesity among its youth. In the last seven years, there has been a 50% increase in the prevalence of obesity as defined by a Body Mass Index (BMI) > 30 kg/m². For the morbidly obese adult, which is defined as having a BMI > 35 kg/m², mortality is increased by 152 to 279%. In a Veterans Administration study of obese 25-34 year old males, there was a 13-fold excess mortality rate over 7½ years.

As in adults, risks associated with childhood and adolescent obesity include elevated blood pressure and cholesterol levels, predisposing these individuals to cardiovascular disease. In addition, a significant number of obese youth have abnormally high concentrations of insulin, with an attendant increased risk of developing type 2 diabetes mellitus.

Currently, limited options are available to help such individuals. While attempts at lifestyle change (e.g., altering diet and activity level) may have some success in the short term, attempts at maintaining weight loss over the long term often fail. Furthermore, there are no current medications that will safely induce significant weight loss over time.

Metformin is an oral antihyperglycemic, insulin-sensitizing agent that has been used in many countries for treatment of type 2 diabetes for more than 40 years. In March 1995, it was approved by the Food and Drug Administration for the treatment of adult type 2 diabetes. Metformin improves insulin sensitivity and reduces insulin resistance by hepatic and peripheral actions. It does not increase insulin secretion.

Further, metformin decreases hepatic glucose production and results in weight loss. Compared to available drugs that act similarly, only metformin has weight-lowering activity, perhaps by increasing nitric oxide production and improving insulin sensitivity. It is also possible that the mild gastrointestinal side effects of metformin induce weight loss. Metformin is therefore often the agent of choice in obese, type 2 diabetics. In a study of non-diabetic obese adults, treatment with metformin resulted in decreased food intake, and decreased body weight and fat.

This is a randomized, double blind, placebo controlled, multi-center clinical trial. The primary outcome measure that will be used to test the study hypothesis is change in BMI from week 0 to week 52, as well as change in BMI from week 0 to week 100. Approximately 135 potential subjects will be screened at the participating institutions, and an expected 76 subjects will be randomized into the study.

Conditions
Obesity
Being tested
glucophage XR
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • glucophage XRDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Study completionNov 2007

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
76 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209482
Sponsor's protocol ID
GPRN410.PL2.02
Status last verified
Nov 2005
First submitted
13 Sep 2005
Last updated
5 Oct 2006
Results posted
No

Publications

  • Wilson DM, Abrams SH, Aye T, Lee PD, Lenders C, Lustig RH, Osganian SV, Feldman HA; Glaser Pediatric Research Network Obesity Study Group. Metformin extended release treatment of adolescent obesity: a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up. Arch Pediatr Adolesc Med. 2010 Feb;164(2):116-23. doi: 10.1001/archpediatrics.2009.264.

    PubMed 20124139

  • Lenders CM, Feldman HA, Von Scheven E, Merewood A, Sweeney C, Wilson DM, Lee PD, Abrams SH, Gitelman SE, Wertz MS, Klish WJ, Taylor GA, Chen TC, Holick MF; Elizabeth Glaser Pediatric Research Network Obesity Study Group. Relation of body fat indexes to vitamin D status and deficiency among obese adolescents. Am J Clin Nutr. 2009 Sep;90(3):459-67. doi: 10.3945/ajcn.2008.27275. Epub 2009 Jul 29.

    PubMed 19640956

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing glucophage XR in people with Obesity, run by Glaser Pediatric Research Network at 5 sites 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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 5 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00209482, which also lists 2 linked publications.

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 5 Oct 2006.

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Glaser Obesity Study (NCT00209482) | AzTrials