Protocol Details

Safety and Efficacy of Orlistat (Xenical, Hoffmann LaRoche) in African American and Caucasian Children and Adolescents with Obesity-Related Comorbid Conditions

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	98-CH-0111
Sponsoring Institute	National Institute of Child Health and Human Development (NICHD)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 12 Max Age: 17
Referral Letter Required	No
Population Exclusion(s)	American Indian or Alaskan Native; Asian/Pacific Islander; Hispanic
Special Instructions	Currently Not Provided
Keywords	Dyslipidemia; Race; Body Fat; Visceral Fat; Sleep Apnea; Fat-Soluble Vitamins; Type 2 Diabetes
Recruitment Keyword(s)	Obesity; Childhood Obesity
Condition(s)	Diabetes Mellitus; Hypertension; Metabolic Disease; Obesity; Sleep Apnea Syndrome
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: Orlistat
Supporting Site	National Institute of Child Health and Human Development

Obesity is a condition affecting one-third off the U.S. 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 1/3 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).

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Eligibility

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

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Citations:

Increasing prevalence of overweight among US adults: the national health and nutrition examination surveys 1960 to 1991

A lipase inhibitor in the treatment of human obesity: a multiple dose study

Long-term morbidity and mortality of overweight adolescents; a follow-up of the Harvard growth study of 1922 to 1935

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Jack A. Yanovski, M.D. National Institute of Child Health and Human Development (NICHD) National Institutes of Health Building 10 Room 5-2571 10 Center Drive Bethesda, Maryland 20892 (301) 435-4432 fdporter@mail.nih.gov	Jack A. Yanovski, M.D. National Institute of Child Health and Human Development (NICHD) National Institutes of Health Building 10 Room 1-3330 10 Center Drive Bethesda, Maryland 20892-1103 (301) 594-2005 sconley@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001723

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