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Metformin Obesity Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00120146
First received: July 7, 2005
Last updated: January 17, 2006
Last verified: January 2006
  Purpose

This trial will test the hypothesis that among obese adolescents, treatment with extended-release metformin (Glucophage® XR), coupled with a lifestyle intervention, will result in decreased obesity (as measured by body mass index [BMI]) as compared to subjects who receive treatment with placebo and the same lifestyle intervention.


Condition Intervention Phase
Obesity
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: A Multi-Center, Randomized, Placebo Controlled, Double- Blind Trial of Metformin in Obese Adolescents

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Change in BMI
  • Body mass index (BMI)

Secondary Outcome Measures:
  • Change in insulin sensitivity
  • Fasting insulin concentrations
  • Characterization of insulin dynamics and insulin sensitivity
  • Characterization of fat distribution and fatty infiltration of the liver
  • Use of CT to characterize abdominal fat distribution
  • Use of CT and ALT levels to assess fatty infiltration of the liver
  • Characterization of body composition
  • Characterization of dietary amino acids
  • Characterization of the insulin/glucagon ratio
  • Characterization of the impact of gender on response to metformin XR
  • Characterization of the impact of race/ethnicity on response to metformin XR
  • Characterization of health-related quality of life

Estimated Enrollment: 22
Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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, and must weigh less than 300 pounds (< 136 kilograms) at week 0 (Baseline)
  • Completion of informed consent/assent process

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

  • Known diabetes as defined by the American Diabetes Association criteria.
  • Prior drug therapy to treat diabetes or insulin insensitivity
  • Has ever used a medication to aid in weight loss
  • 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.

  • Recent glucocorticoid therapy
  • History of any syndrome or medical disorder associated with significant obesity
  • Recent history of involvement in a formal weight loss program
  • Alcohol use
  • 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).

An AST or ALT of > 2 times upper limit of normal was chosen based on data which show that approximately 5% of obese adolescents have liver enzymes greater than 2 times the upper limit of normal in the clinical setting.

  • 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. Females who have had at least one menstrual cycle must either be abstinent or must consistently be using an effective method of birth control (e.g., intrauterine contraceptive device, oral contraceptive or medroxyprogesterone acetate or barrier method [diaphragm or condom] plus contraceptive jelly, cream, or foam) during the study. This will be documented at each visit. Additionally, all females who have begun menstruating must have a negative result on the urine pregnancy test administered at every visit in order to remain on study drug and undergo radiologic procedures.
  • Previous pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120146

Locations
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
Principal Investigator: Carine Lenders, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120146     History of Changes
Other Study ID Numbers: 05-09-132R
Study First Received: July 7, 2005
Last Updated: January 17, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014