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Clinical Trials/NL-OMON39499
NL-OMON39499CompletedPhase 3

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

Sint Antonius Ziekenhuis0 sites144 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
144
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
2 to 17 (—)

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.

Investigators

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