Glaser Obesity Study

NCT00209482 | Unknown Phase 2

• 1 other identifier: GPRN410.PL2.02
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (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.

Interventions

glucophage XR DRUG

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Glaser Pediatric Research Network: lead
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 20124139 DERIVED

• 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.

  PMID: 19640956 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Darrell M Wilson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2003
• Study Completion: November 1, 2007
• Last Updated: October 5, 2006

Record last verified: 2005-11

Locations

US (5)