FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003816-47-DE
Enrollment
Unknown
Registered
2005-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insuline-resistance in adipose children and adolescents

Interventions

Product Name: Metformin Pharmaceutical Form: Capsule* INN or Proposed INN: Metformin hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutic

Sponsors

Pädiatrische Endokrinologie, Universitätsmedizin Berlin, Charité
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: Glucose tolerance Lipid serum level Elevated liver enzymes Blood pressure;Primary end point(s): Change in insuline resistance (according to HOMA) after 6 months of therapy—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026