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.

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)

166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).
Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia

Metformin

173 were randomized to receive placebo
Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one

Placebo

Total

Gender

The BMI SDS is calculated by; (BMI value of the subject - median value of the population)/Standard deviation of the population.
This will provide how far the measured individuals BMI is deviated from the median in multiples of the SD value of the population. Value could be either positive (if measured value is greater than the median) or a negative value (if measured value is less than the median).

BMI Standard Deviation Score

Percentage fat mass

The Percent Fat Mass SDS is calculated by; (Percent FM of the subject - median value of the population)/Standard deviation of the population.
This will provide how far the measured individuals Percent FM is deviated from the median in multiples of the SD value of the population. Value could be either positive (if measured value is greater than the median) or a negative value (if measured value is less than the median).

Percentage Fat Mass Standard Deviation Score

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.

After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)

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

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.

After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)

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

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)

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

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.

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

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.

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

8-10.99 year old children will receive metformin. Initially children will be 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 will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.
Metformin: A dummy tablet similar to Metformin will be administer to the control group

A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)
Metformin: A dummy tablet similar to Metformin will be administer to the control group

Overall Study

Prof V Pujitha Wickramasinghe

8-10.99 year old children received metformin. Initially children were 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 increased to 500mg twice daily for a week and then to 1g twice daily.
Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events.

The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group
Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events.

Pediatric Obesity

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

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

aspartate amino transferase/השמנת יתר חולנית

Use of Metformin in Treatment of Childhood Obesity

המאגר השלם ביותר של צמחי מרפא המגובה על ידי המדע