Metformin Obesity Study

Condition(s) targeted: Obesity

Intervention: Metformin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Carine Lenders, MD, Principal Investigator, Affiliation: Children's Hospital Boston

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.

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

Study design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Primary outcome:

Change in BMI

Body mass index (BMI)

Secondary outcome:

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

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

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

Children's Hospital, Boston, Boston, Massachusetts 02115, United States

Starting date: October 2002
Last updated: January 17, 2006