Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005669
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2000-05-19
Brief Title:
Metformin to Treat Obesity in Children With Insulin Resistance
Sponsor:
Jack Yanovski MD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Metformin on Energy Intake Energy Expenditure and Body Weight in Overweight Children With Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of the medicine metformin to help overweight children control their food intake weight insulin cholesterol and triglyceride blood fat levels Obesity and high insulin levels can lead to high blood pressure diabetes high cholesterol and triglyceride levels and heart disease Metformin-approved by the Food and Drug Administration to treat adults with type 2 diabetes mellitus-helps lower insulin levels and may control weight gain in adults
Overweight children 6 to 11 years old who are in general good health may be eligible for this study Children will be studied at the National Institutes of Health in Bethesda Maryland Candidates will have a medical history and physical examination and fasting blood test and will provide a 7-day record of their food intake as part of the screening process Those enrolled will be randomly assigned to receive either metformin or placebo a look-alike tablet with no active medicine twice a day for a six month period After the 6 month study period all children will be offered the opportunity to take metformin for another 6 months
Participants will be hospitalized for 2-3 days for the following procedures history and physical examination fasting blood test several urine collections X-ray studies to determine bone age and amount of body fat and muscle magnetic resonance imaging MRI scan to measure body fat hyperglycemic clamp study to evaluate insulin resistance food intake testing nutrition consultation resting metabolic rate and a doubly labeled water test
For the hyperglycemic clamp study a catheter thin flexible tube is inserted into a vein in each arm A sugar solution is given through one tube and blood samples are drawn every 5 minutes through the other to measure insulin For the food intake testing the child is asked about his or her hunger level then given various foods he or she may choose to eat then questioned again at various intervals both during and after finishing eating about his or her hunger level The doubly labeled water study involves drinking heavy water water which is enriched to have special kinds of hydrogen and oxygen Urine specimens are collected 2 3 and 4 hours after drinking the water The child also drinks a special milk shake called a Scandishake and repeats the calorie intake and hunger study Two food intake studies are done on separate days One week after the heavy water test additional urine samples are collected one week later
After completing the tests the child will begin treatment with metformin or placebo plus a daily vitamin tablet Participants will be followed once a month with a brief history and physical examination including a blood test After 6 months all of the tests described above will be repeated All children who complete the second round of tests-both those who took metformin and those who took placebo-will be offered metformin for an additional 6 months and will be seen once a month for follow-up evaluations Parents will not be told which children received metformin and which received placebo until all children in the study complete the first 6 months of the trial
Overweight children 6 to 11 years old who are in general good health may be eligible for this study Children will be studied at the National Institutes of Health in Bethesda Maryland Candidates will have a medical history and physical examination and fasting blood test and will provide a 7-day record of their food intake as part of the screening process Those enrolled will be randomly assigned to receive either metformin or placebo a look-alike tablet with no active medicine twice a day for a six month period After the 6 month study period all children will be offered the opportunity to take metformin for another 6 months
Participants will be hospitalized for 2-3 days for the following procedures history and physical examination fasting blood test several urine collections X-ray studies to determine bone age and amount of body fat and muscle magnetic resonance imaging MRI scan to measure body fat hyperglycemic clamp study to evaluate insulin resistance food intake testing nutrition consultation resting metabolic rate and a doubly labeled water test
For the hyperglycemic clamp study a catheter thin flexible tube is inserted into a vein in each arm A sugar solution is given through one tube and blood samples are drawn every 5 minutes through the other to measure insulin For the food intake testing the child is asked about his or her hunger level then given various foods he or she may choose to eat then questioned again at various intervals both during and after finishing eating about his or her hunger level The doubly labeled water study involves drinking heavy water water which is enriched to have special kinds of hydrogen and oxygen Urine specimens are collected 2 3 and 4 hours after drinking the water The child also drinks a special milk shake called a Scandishake and repeats the calorie intake and hunger study Two food intake studies are done on separate days One week after the heavy water test additional urine samples are collected one week later
After completing the tests the child will begin treatment with metformin or placebo plus a daily vitamin tablet Participants will be followed once a month with a brief history and physical examination including a blood test After 6 months all of the tests described above will be repeated All children who complete the second round of tests-both those who took metformin and those who took placebo-will be offered metformin for an additional 6 months and will be seen once a month for follow-up evaluations Parents will not be told which children received metformin and which received placebo until all children in the study complete the first 6 months of the trial
Detailed Description:
The prevalence of overweight and obesity in children and adolescents in the United States has doubled during the past 20 years Obesity is closely linked with development of insulin resistance and other mediators of unfavorable cardiovascular risk such as hypertension and dyslipidemia These obesity-related risk factors often first appear during childhood Since obese children tend to become obese adults such children are at increased risk for persistence of these abnormalities into adulthood and for the early occurrence of obesity-related morbidity and mortality Obesity-related insulin resistance is also largely responsible for the recently documented rise in the incidence of Type 2 diabetes in youth To date there is no FDA-approved pharmacotherapy for children with obesity and insulin resistance Metformin is a medication approved for use in adults with Type 2 diabetes that is unique in that it promotes weight loss and improves features of the insulin resistance syndrome Preliminary studies suggest that metformin may promote weight loss in obese non-diabetic children However the mechanism of metformin-induced weight loss has not been elucidated We propose to evaluate the safety tolerability efficacy and mechanism of metformin-induced weight loss in obese hyperinsulinemic children aged 6-1299 years We will conduct a six-month randomized double blind placebo-controlled trial of metformin All study participants will receive nutritional consultation and advice on appropriate diet We will study the effects of metformin on weight food intake energy expenditure insulin sensitivity and lipids At the end of the six-month placebo-controlled trial all subjects will be offered metformin in an open label phase for an additional six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CH-0134 | OTHER | NIH Clinical Center | None |