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Metformin to Treat Obesity in Children With Insulin Resistance

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: NCT00005669
Recruitment Status : Completed
First Posted : May 22, 2000
Results First Posted : April 7, 2011
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jack Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hyperinsulinemia
Obesity
Interventions Drug: Metformin HCL
Drug: Placebo
Enrollment 100
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 53 47
Completed 45 40
Not Completed 8 7
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 53 47 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 47 participants 100 participants
<=18 years
53
 100.0%
47
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 47 participants 100 participants
10.1  (1.6) 10.4  (1.4) 10.2  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 47 participants 100 participants
Female
30
  56.6%
30
  63.8%
60
  60.0%
Male
23
  43.4%
17
  36.2%
40
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 47 participants 100 participants
53 47 100
1.Primary Outcome
Title Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.11
(-0.16 to -0.05)
-0.07
(-0.12 to -0.01)
2.Secondary Outcome
Title Change in Body Weight as Determined by BMI
Hide Description Change in body weight as determined by body mass index (kg/m2)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: kg/m2
-0.78
(-1.54 to -0.01)
0.32
(-0.54 to 1.18)
3.Secondary Outcome
Title Change in Body Weight
Hide Description Change in body weight (kg)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: kg
1.47
(-0.31 to 3.24)
4.85
(2.84 to 6.85)
4.Secondary Outcome
Title Change in Body Fat by DEXA
Hide Description Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, multiple imputation model for missing data under a missing-at-random assumption
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: kg
0.48
(-0.80 to 1.76)
1.88
(0.44 to 3.31)
5.Secondary Outcome
Title Change in Body Fat by Bod Pod
Hide Description Change in body fat mass measured by air displacement plethysmography (kg)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 53 47
Mean (95% Confidence Interval)
Unit of Measure: kg
-1.51
(-4.56 to 1.54)
1.81
(-1.64 to 5.25)
Time Frame 6 months
Adverse Event Reporting Description Pharmacist-administered comprehensive structured questionnaire at baseline and follow-up timepoints plus case report forms with specific questions related to expected toxicities of metformin.
 
Arm/Group Title Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Hide Arm/Group Description 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 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
All-Cause Mortality
Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/47 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metformin Plus Weight Reduction Counseling Placebo Plus Weight Reduction Counseling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/53 (90.57%)      46/47 (97.87%)    
Gastrointestinal disorders     
Nausea  1  28/53 (52.83%)  55 17/47 (36.17%)  18
Liquid Stools  1  22/53 (41.51%)  34 8/47 (17.02%)  8
Vomiting  1  22/53 (41.51%)  36 10/47 (21.28%)  10
Bloating  1  13/53 (24.53%)  20 6/47 (12.77%)  7
Increased Bowel Movements  1  22/53 (41.51%)  25 11/47 (23.40%)  13
General disorders     
Fatigue  1  20/53 (37.74%)  29 7/47 (14.89%)  10
Decreased Happiness  1  14/53 (26.42%)  14 6/47 (12.77%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jack A. Yanovski, MD, PhD, Chief, Unit on Growth and Obesity
Organization: National Institute of Child Health and Human Development, NIH
Phone: 301-496-0858
EMail: yanovskj@mail.nih.gov
Layout table for additonal information
Responsible Party: Jack Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00005669    
Other Study ID Numbers: 000134
00-CH-0134 ( Other Identifier: NIH Clinical Center )
First Submitted: May 19, 2000
First Posted: May 22, 2000
Results First Submitted: April 7, 2010
Results First Posted: April 7, 2011
Last Update Posted: May 8, 2015