An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents.

Phase 3

Completed

Conditions: Bariatrie (Obesitas)
excess body fat
Obese

Registration Number: NL-OMON39499

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 144

Inclusion Criteria

The inclusion criteria are subject*s age >= 10 and <= 16 years at study entry, from Caucasian descent, with obesity defined as BMI SDS > 2.3 and with insulin resistance defined as HOMA-IR >= 3.4. In addition an obtained informed consent from subjects and/or parents/caregivers.

Exclusion Criteria

The exclusion criteria are 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; psychiatric illness and eating disorders in particular; 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<80ml/min and ALAT >= 150% of normal value for age); use of ritonavir; use of ACE inhibitors; insufficient knowledge of the Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint for efficacy is the reduction in BMI, which is<br /><br>calculated from the anthropometric measurements.<br /><br>Other primary endpoints for efficacy are insulin resistance, calculated by the<br /><br>HOMA-IR, which is a generally accepted index to determine insulin resistance in<br /><br>children and adolescents, percentage of body fat measured by bio-impedance,<br /><br>HbA1C value, β-cell function, calculated by HOMA-β%, oral disposition index,<br /><br>insulin secretion calculated by the insulinogenic index, physical fitness<br /><br>measured by validated fitness tests, basal metabolic rate measured by<br /><br>calorimetry and quality of life measured by validated quality of life<br /><br>questionnaire. </p><br>

Secondary Outcome Measures