Protocol Number: 98-CH-0111

Title:

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

Number:

98-CH-0111

Summary:

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).

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): American Indian or Alaskan Native

Asian/Pacific Islander

Hispanic

Eligibility Criteria: 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.

Special Instructions:

Currently Not Provided

Keyword(s):

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):

Orlistat

Investigational Device(s):

None

Interventions:

Drug: Orlistat

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

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.

Citation(s):

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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