Metformin in Obese Children and Adolescents

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Antonius Hospital
• Collaborator: Jeroen Bosch Ziekenhuis
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Age ≥ 10 and ≤ 16 years at study entry

• Caucasian descent

• Obesity defined as BMI-SDS > 2.3

• Insulin resistance defined as HOMA-IR ≥ 3.4.

• An obtained informed consent from subjects and parents/caregivers.

Exclusion Criteria:

• Presence of T2DM (American Diabetes Association criteria)

• Presence of endocrine disorders with steroid therapy

• Suspicion of polycystic ovarium syndrome;

• Height < -1.3 SD of target height;

• Syndrome disorders with or without mental retardation;

• Use of anti-hyperglycaemic drugs;

• Pregnancy (pregnancy test will be performed, if applicable);

• (History of) alcohol abuse;

• Impaired renal and/or hepatic function (defined as GFR < 80 ml/min. GFR=40 x length (cm) / serumcreatinin (μmol/l and ALAT >150% of normal value for age);

• Use of ritonavir; use of ACE inhibitors;

• Insufficient knowledge of the Dutch language.