Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001723
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
1999-11-03
Brief Title:
Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
Sponsor:
Jack Yanovski
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety and Efficacy of Orlistat Xenical Hoffmann LaRoche in African American and Caucasian Children and Adolescents With Obesity-Related Comorbid Conditions
Status:
COMPLETED
Status Verified Date:
2012-11
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:
Obesity is a condition affecting one-third off the US population and is a major risk actor for the development of Type 2 diabetes hyperlipidemia increased levels of fat in the blood hypertension high blood pressure and other disorders of the heart and lungs Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related diseases both during adolescence and later in adult life
African American girls and women are at an increased risk for obesity and have substantial rates of obesity-related diseases and causes of death Further many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents
One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat Xenical Hoffmann LaRoche Orlistat works by preventing the action of enzymes in the digestive process interfering with the absorption of approximately 13 of the fat eaten in the diet Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults
Researchers propose to determine the safety tolerability and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease hypertension hyperlipidemia sleep apnea hepatic steatosis insulin resistance impaired glucose tolerance or Type 2 diabetes
African American girls and women are at an increased risk for obesity and have substantial rates of obesity-related diseases and causes of death Further many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents
One medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat Xenical Hoffmann LaRoche Orlistat works by preventing the action of enzymes in the digestive process interfering with the absorption of approximately 13 of the fat eaten in the diet Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults
Researchers propose to determine the safety tolerability and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease hypertension hyperlipidemia sleep apnea hepatic steatosis insulin resistance impaired glucose tolerance or Type 2 diabetes
Detailed Description:
Obesity is a condition affecting one-third of the adult US population and is a major risk factor for the development of Type 2 diabetes hyperlipidemia hypertension and other cardiovascular and respiratory disorders Individuals with the onset of obesity during childhood or adolescence are at increased risk for obesity-related comorbid conditions both during adolescence and later in life African American girls and women are at particular risk for obesity and have substantial rates of obesity-related morbidity and mortality Further African American adult women have a less satisfactory response to many therapeutic approaches used to treat obesity At present there are no medical therapies proven effective for the amelioration of severe obesity in children or adolescents One medication that may have a favorable risk-benefit ratio in pediatric populations is orlistat XenicalTrademark Hoffmann LaRoche Orlistat acts by inhibiting gastrointestinal lipases interfering with the absorption of approximately 13 of ingested dietary fat Orlistat appears to be effective for reducing weight and obesity-associated comorbidities in obese adults We propose to determine the safety tolerability and efficacy of orlistat in 12-17 year-old severely obese African American and Caucasian children and adolescents who have one or more obesity-related comorbidity hypertension hyperlipidemia sleep apnea hepatic steatosis insulin-resistance impaired glucose tolerance or Type 2 diabetes Under this protocol we have conducted an open-label pilot study of orlistat in twenty subjects suggesting orlistat has a similar side effect profile in adolescents as in adults We wish to determine the safety and efficacy of orlistat in reducing obesity-related comorbidities using a randomized double-blind placebo-controlled clinical trial All study participants will be enrolled in a psycho-educational weight loss program that includes nutrition education cognitive-behavioral self-monitoring strategies and promotion of physical activity We will also study the effects of orlistat on fat preferences and study the influence of genetic variables on energy expenditure and weight loss during treatment A group of healthy non-overweight children and adolescents will complete questionnaires and exercise studies as a control group for interpretation of results in overweight children and adolescents but will not undergo phlebotomy or receive any medication
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 |
|---|---|---|---|
| 98-CH-0111 | OTHER | NICHD IRB | None |