Trial Outcomes & Findings for Use of Metformin in Treatment of Childhood Obesity (NCT NCT02274948)
NCT ID: NCT02274948
Last Updated: 2017-01-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
339 participants
Primary outcome timeframe
One year
Results posted on
2017-01-02
Participant Flow
Obese (defined as ≥+2SD of BMI for age, WHO 2007 standards) children of 8-16 years of age were identified through a separate screening programme carried out in all schools in the Negombo educational zone and were invited to participate in this study. Study commenced in July 2014
Selected children were invited to participate in the research and provide clinical service. Consent from parents and assent from children obtained. After baseline assessment randomly assigned to receive one of the two management protocols on a 1:1 basis. Children were stratified according to gender and age groups; 8-10.99; 11-16 years
Participant milestones
| Measure |
Metformin
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
|
Placebo
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
STARTED
|
166
|
173
|
|
Overall Study
COMPLETED
|
68
|
82
|
|
Overall Study
NOT COMPLETED
|
98
|
91
|
Reasons for withdrawal
| Measure |
Metformin
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
|
Placebo
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
Lost to Follow-up
|
28
|
25
|
|
Overall Study
Withdrawal by Subject
|
64
|
58
|
|
Overall Study
Stopped on family Practitioner advice
|
2
|
5
|
|
Overall Study
Left the area
|
4
|
3
|
Baseline Characteristics
Use of Metformin in Treatment of Childhood Obesity
Baseline characteristics by cohort
| Measure |
Metformin
n=166 Participants
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
|
Placebo
n=173 Participants
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
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.92 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
11.95 years
STANDARD_DEVIATION 2.34 • n=7 Participants
|
11.94 years
STANDARD_DEVIATION 2.31 • n=5 Participants
|
|
Gender
Female
|
78 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Gender
Male
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
BMI
|
27.89 kg/m^2
STANDARD_DEVIATION 3.53 • n=5 Participants
|
27.57 kg/m^2
STANDARD_DEVIATION 3.32 • n=7 Participants
|
27.73 kg/m^2
STANDARD_DEVIATION 3.42 • n=5 Participants
|
|
BMI Standard Deviation Score
|
2.58 units on a scale
STANDARD_DEVIATION 0.42 • n=5 Participants
|
2.54 units on a scale
STANDARD_DEVIATION 0.42 • n=7 Participants
|
2.56 units on a scale
STANDARD_DEVIATION 0.42 • n=5 Participants
|
|
Percentage fat mass
|
43.02 Percent
STANDARD_DEVIATION 5.14 • n=5 Participants
|
42.88 Percent
STANDARD_DEVIATION 5.03 • n=7 Participants
|
42.95 Percent
STANDARD_DEVIATION 5.08 • n=5 Participants
|
|
Percentage Fat Mass Standard Deviation Score
|
2.82 units on a scale
STANDARD_DEVIATION 0.42 • n=5 Participants
|
2.81 units on a scale
STANDARD_DEVIATION 0.44 • n=7 Participants
|
2.82 units on a scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: One yearBMI 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.
Outcome measures
| Measure |
Metformin
n=68 Participants
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)
|
Placebo
n=82 Participants
173 were randomized to receive placebo
|
|---|---|---|
|
Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo
BMI Z score
|
-0.370 Z score
Interval -0.44 to -0.303
|
-0.22 Z score
Interval -0.284 to -0.159
|
|
Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo
Percentage Fat Mass Z score
|
-0.139 Z score
Interval -0.207 to -0.07
|
-0.065 Z score
Interval -0.13 to -0.005
|
SECONDARY outcome
Timeframe: One yearFasting 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.
Outcome measures
| Measure |
Metformin
n=68 Participants
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)
|
Placebo
n=82 Participants
173 were randomized to receive placebo
|
|---|---|---|
|
Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo
|
-58.08 pmol/l
Interval -111.68 to -4.55
|
-26.48 pmol/l
Interval -77.3 to 24.37
|
SECONDARY outcome
Timeframe: One yearHOMA 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)
Outcome measures
| Measure |
Metformin
n=68 Participants
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)
|
Placebo
n=82 Participants
173 were randomized to receive placebo
|
|---|---|---|
|
Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo
|
-1.77 units on a scale
Interval -2.577 to -0.98
|
-0.792 units on a scale
Interval -1.549 to -0.035
|
SECONDARY outcome
Timeframe: One yearTriglyceride 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.
Outcome measures
| Measure |
Metformin
n=68 Participants
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)
|
Placebo
n=82 Participants
173 were randomized to receive placebo
|
|---|---|---|
|
Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo
|
-0.33 mmol/l
Interval -0.45 to -0.22
|
-0.14 mmol/l
Interval -0.25 to -0.04
|
SECONDARY outcome
Timeframe: One yearALT 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.
Outcome measures
| Measure |
Metformin
n=68 Participants
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)
|
Placebo
n=82 Participants
173 were randomized to receive placebo
|
|---|---|---|
|
Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo
|
-0.02 Iu/l
Interval -0.07 to 0.44
|
0.01 Iu/l
Interval -0.04 to 0.05
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=166 participants at risk
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.
|
Placebo
n=173 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.0%
5/166 • Number of events 11 • 13 months (1 month after stopping treatment)
|
4.6%
8/173 • Number of events 8 • 13 months (1 month after stopping treatment)
|
|
Gastrointestinal disorders
Nausea
|
11.4%
19/166 • Number of events 34 • 13 months (1 month after stopping treatment)
|
5.8%
10/173 • Number of events 18 • 13 months (1 month after stopping treatment)
|
|
Gastrointestinal disorders
Anorexia
|
19.9%
33/166 • Number of events 62 • 13 months (1 month after stopping treatment)
|
16.2%
28/173 • Number of events 36 • 13 months (1 month after stopping treatment)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
16/166 • Number of events 18 • 13 months (1 month after stopping treatment)
|
6.9%
12/173 • Number of events 12 • 13 months (1 month after stopping treatment)
|
|
Nervous system disorders
Headache
|
2.4%
4/166 • Number of events 8 • 13 months (1 month after stopping treatment)
|
3.5%
6/173 • Number of events 6 • 13 months (1 month after stopping treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
7/166 • Number of events 10 • 13 months (1 month after stopping treatment)
|
2.3%
4/173 • Number of events 6 • 13 months (1 month after stopping treatment)
|
|
Gastrointestinal disorders
Gastro oesophageal reflux like symptoms
|
1.2%
2/166 • Number of events 2 • 13 months (1 month after stopping treatment)
|
1.2%
2/173 • Number of events 2 • 13 months (1 month after stopping treatment)
|
|
Nervous system disorders
Sleepyness
|
0.60%
1/166 • Number of events 1 • 13 months (1 month after stopping treatment)
|
1.7%
3/173 • Number of events 3 • 13 months (1 month after stopping treatment)
|
|
Nervous system disorders
Vertigo
|
0.00%
0/166 • 13 months (1 month after stopping treatment)
|
1.2%
2/173 • Number of events 2 • 13 months (1 month after stopping treatment)
|
|
Nervous system disorders
Faintishness
|
6.6%
11/166 • Number of events 11 • 13 months (1 month after stopping treatment)
|
2.9%
5/173 • Number of events 5 • 13 months (1 month after stopping treatment)
|
|
Skin and subcutaneous tissue disorders
papular rash
|
0.00%
0/166 • 13 months (1 month after stopping treatment)
|
0.58%
1/173 • Number of events 1 • 13 months (1 month after stopping treatment)
|
|
Musculoskeletal and connective tissue disorders
Calf Cramp
|
0.60%
1/166 • Number of events 1 • 13 months (1 month after stopping treatment)
|
0.00%
0/173 • 13 months (1 month after stopping treatment)
|
Additional Information
Prof V Pujitha Wickramasinghe
Faculty of Medicine, University of Colombo
Phone: +94112688748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place