Use of Metformin in Treatment of Childhood Obesity

NCT02274948 | Completed Phase 4 Results

• 1 other identifier: EC-13-143
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo

  BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.

  One year

Secondary Outcomes (4)

• Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo

  One year

• Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo

  One year

• Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo

  One year

• Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo

  One year

Study Arms (2)

Metformin

ACTIVE COMPARATOR

8-10.99 year old children received metformin. Initially children given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week which increased to 500mg twice daily for a week and then to 1g twice daily. The medication was continued for 12 months.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above. Metformin and placebo is manufactured by the State Pharmaceutical Manufacturing Corporation (SPMC)

Drug: Placebo

Interventions

Metformin DRUG

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

Also known as: Generic Metformin Produced by SPMC, Sri Lanka

Metformin

Placebo DRUG

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

Also known as: Placebo manufactured by SPMC, Sri Lanka

Placebo

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Obese children (based on \>+2SD of BMI to age on WHO 2007 standards)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colombo: lead

Study Sites (1)

Lions Club of Negombo Host

Negombo, Western Province, Sri Lanka

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Prof V Pujitha Wickramasinghe
• Organization: Faculty of Medicine, University of Colombo

pujithaw@yahoo.com

+94112688748

Study Officials

• Vithanage P Wickramasinghe, MD, PhD

  University of Colombo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Paediatrics

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 27, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 2, 2017
• Results First Posted: January 2, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

SR (1)