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Metformin in Obese Children and Adolescents

NCT01487993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-04-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Metformin

Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.

BEHAVIORAL

Lifestyle intervention

Lifestyle intervention: 18 months physical therapy and dietary advice

Sponsors & Collaborators

  • Jeroen Bosch Ziekenhuis

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Marja MJ van der Vorst, MD, PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-08-31
Completion
2017-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01487993 on ClinicalTrials.gov