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Use of Metformin in Treatment of Childhood Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274948
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Pujitha Wickramasinghe, University of Colombo

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.


Condition or disease Intervention/treatment Phase
Pediatric Obesity Drug: Metformin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Metformin on Body Weight, Composition and Metabolic Derangements in Obese Children. A Randomized Clinical Trial
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin
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
Metformin in the form of 500mg tablets were administer to the Metformin group
Other Name: Generic Metformin Produced by SPMC, Sri Lanka

Placebo Comparator: Placebo

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
A Placebo tablet physically and chemically similar to Metformin tablets except for the absence of the active ingredient was used
Other Name: Placebo manufactured by SPMC, Sri Lanka




Primary Outcome Measures :
  1. Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo [ Time Frame: One year ]
    Fasting insulin 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.

  2. Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo [ Time Frame: One year ]

    HOMA IR (Homeostatic model -Insulin Resistance) 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.

    Homeostatic model (HOMA-IR = fasting blood sugar(mmol/l) × fasting insulin(mmol/l) ÷ 22.5)


  3. Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo [ Time Frame: One year ]
    Triglyceride was measured 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.

  4. Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo [ Time Frame: One year ]
    ALT was measured 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.



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274948


Locations
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Sri Lanka
Lions Club of Negombo Host
Negombo, Western Province, Sri Lanka
Sponsors and Collaborators
University of Colombo
Investigators
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Principal Investigator: Vithanage P Wickramasinghe, MD, PhD University of Colombo

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Responsible Party: Pujitha Wickramasinghe, Professor in Paediatrics, University of Colombo
ClinicalTrials.gov Identifier: NCT02274948    
Other Study ID Numbers: EC-13-143
First Posted: October 27, 2014    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: January 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs