At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 339 enrolled

Drug / intervention

Metformin +1 moredrug

Likely dose

Metformin 500mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02274948

NCT02274948Phase 4Completed

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Effects of Metformin on Body Weight, Composition and Metabolic Derangements in Obese Children. A Randomized Clinical Trial

University of Colombo·interventional·Posted Oct 27, 2014·Updated Jan 2, 2017

In Brief

A Phase 4 clinical trial evaluating Metformin and Placebo for Pediatric Obesity. Completed, enrolled 339 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPediatric Obesity

CountriesSri Lanka

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartJul 2014

First PostedOct 2014

Primary CompletionSep 2015

Study CompletionApr 2016

TodayJul 2026

First PostedOct 27, 2014

Enrollment StartJul 1, 2014

Primary CompletionSep 1, 2015

Study CompletionApr 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 11.7 years ago

Interventions

Metformindrug

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

Placebodrug

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