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Use of Metformin in Treatment of Childhood Obesity

NCT02274948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2017-01-02

Study results available
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Summary

This study expects to evaluate the use of metformin in the management of obese children. Insulin resistance among obese Sri Lankan children (south Asian origin) is high, which had been shown in the investigators previous work.

This study will look at the effect of metformin on changes in insulin resistance, fatty liver state, body fat content, BMI and other metabolic derangement.

Conditions

  • Pediatric Obesity

Interventions

DRUG

Metformin

Metformin in the form of 500mg tablets were administer to the Metformin group

DRUG

Placebo

A Placebo tablet physically and chemically similar to Metformin tablets except for the absence of the active ingredient was used

Sponsors & Collaborators

  • University of Colombo

    lead OTHER

Principal Investigators

  • Vithanage P Wickramasinghe, MD, PhD · University of Colombo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-09-30
Completion
2016-04-30

Countries

  • Sri Lanka

Study Locations

More Related Trials

Entities

Drugs

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 NCT02274948 on ClinicalTrials.gov