Phase 4
N=339
Use of Metformin in Treatment of Childhood Obesity
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02274948 ↗Enrolled (actual)
339
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo — -0.370; -0.22; -0.139; -0.065 Z score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of Colombo
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo |
-0.370; -0.22; -0.139; -0.065 | — |
| SECONDARY Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo |
-58.08; -26.48 | — |
| SECONDARY Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo |
-1.77; -0.792 | — |
| SECONDARY Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo |
-0.33; -0.14 | — |
| SECONDARY Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo |
-0.02; 0.01 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Obese children (based on >+2SD of BMI to age on WHO 2007 standards)
Exclusion Criteria
- Children not of Sri Lankan origin
- Children who are not planning to live in Sri Lanka during the next one year
- Children with a secondary underlying cause for the overweight/obesity
Data sourced from ClinicalTrials.gov (NCT02274948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.