Trial Outcomes & Findings for Metformin to Treat Obesity in Children With Insulin Resistance (NCT NCT00005669)
NCT ID: NCT00005669
Last Updated: 2015-05-08
Results Overview
Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile\_data\_files.htm for details.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
6 months
Results posted on
2015-05-08
Participant Flow
We recruited subjects from 2000 through 2008. Obese children (BMI 95th percentile or greater), aged 6-12y, were recruited through newspaper advertisements and letters to physicians, and were eligible if they had fasting hyperinsulinemia, (insulin at least 15mU/mL. Following an outpatient screen, participants were admitted for assessments.
Children were excluded if they had impaired fasting glucose or were diabetic, had significant renal, hepatic, cardiac or pulmonary disease, or presence of other endocrinologic disorders leading to obesity, had used prescription or non-prescription weight loss agents, or reported \>2% body weight loss in the preceding 6 months.
Participant milestones
| Measure |
Metformin Plus Weight Reduction Counseling
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
47
|
|
Overall Study
COMPLETED
|
45
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin to Treat Obesity in Children With Insulin Resistance
Baseline characteristics by cohort
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
10.4 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
10.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
47 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile\_data\_files.htm for details.
Outcome measures
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).
|
-0.11 Units on a scale
Interval -0.16 to -0.05
|
-0.07 Units on a scale
Interval -0.12 to -0.01
|
SECONDARY outcome
Timeframe: 6 monthsChange in body weight as determined by body mass index (kg/m2)
Outcome measures
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Change in Body Weight as Determined by BMI
|
-0.78 kg/m2
Interval -1.54 to -0.01
|
0.32 kg/m2
Interval -0.54 to 1.18
|
SECONDARY outcome
Timeframe: 6 monthsChange in body weight (kg)
Outcome measures
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Change in Body Weight
|
1.47 kg
Interval -0.31 to 3.24
|
4.85 kg
Interval 2.84 to 6.85
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT, multiple imputation model for missing data under a missing-at-random assumption
Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)
Outcome measures
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Change in Body Fat by DEXA
|
0.48 kg
Interval -0.8 to 1.76
|
1.88 kg
Interval 0.44 to 3.31
|
SECONDARY outcome
Timeframe: 6 monthsChange in body fat mass measured by air displacement plethysmography (kg)
Outcome measures
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 Participants
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 Participants
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Change in Body Fat by Bod Pod
|
-1.51 kg
Interval -4.56 to 1.54
|
1.81 kg
Interval -1.64 to 5.25
|
Adverse Events
Metformin Plus Weight Reduction Counseling
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo Plus Weight Reduction Counseling
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin Plus Weight Reduction Counseling
n=53 participants at risk
Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
Placebo Plus Weight Reduction Counseling
n=47 participants at risk
Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
52.8%
28/53 • Number of events 55 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
36.2%
17/47 • Number of events 18 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
Gastrointestinal disorders
Liquid Stools
|
41.5%
22/53 • Number of events 34 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
17.0%
8/47 • Number of events 8 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
Gastrointestinal disorders
Vomiting
|
41.5%
22/53 • Number of events 36 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
21.3%
10/47 • Number of events 10 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
Gastrointestinal disorders
Bloating
|
24.5%
13/53 • Number of events 20 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
12.8%
6/47 • Number of events 7 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
Gastrointestinal disorders
Increased Bowel Movements
|
41.5%
22/53 • Number of events 25 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
23.4%
11/47 • Number of events 13 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
General disorders
Fatigue
|
37.7%
20/53 • Number of events 29 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
14.9%
7/47 • Number of events 10 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
|
General disorders
Decreased Happiness
|
26.4%
14/53 • Number of events 14 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
12.8%
6/47 • Number of events 9 • 6 months
Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
|
Additional Information
Jack A. Yanovski, MD, PhD, Chief, Unit on Growth and Obesity
National Institute of Child Health and Human Development, NIH
Phone: 301-496-0858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place