Clinical pilot study on the effect of Metformin in adipose children and adolescents with insulin-resistanceKlinische Pilotstudie zur Untersuchung der Wirkung von Metformin bei adipösen Kindern und Jugendlichen mit Insulin-Resistenz (IR) - not available

Phase 1

Conditions: Insuline-resistance in adipose children and adolescents

Registration Number: EUCTR2004-003816-47-DE

Lead Sponsor: Pädiatrische Endokrinologie, Universitätsmedizin Berlin, Charité

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age from 10 to 17 years
HOMA > 3
BMI > 95. percentile (based on reference percentile according to AGA)
Ineffective multidisciplinary treatment of adiposity for at least 6 months
In females: highly effective method of birth control used consistently and correctly (e.g. oral contraceptives, see protocol)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diabetes mellitus (according to criteria of the WHO)
Decrease in BMI > -2 within 6 months
Elevation of GOT and GPT Serum levels (> 150% of the upper referential value)
Elevation of Creatinine Serum levels
Decrease of Creatinine-clearance
All contraindications to Metformin hydrochloride (see protocol)
In females: sexual activity and contraindication for oral contraceptives

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of the insuline resistance (assessed on the basis of HOMA (homeostasis model assessment);Secondary Objective: Improvement of the metabolic syndrome in regard to:<br>Glucose tolerance<br>Lipid serum level<br>Elevated liver enzymes<br>Blood pressure;Primary end point(s): Change in insuline resistance (according to HOMA) after 6 months of therapy<br>

Secondary Outcome Measures