Brain-Derived Neurotrophic Factor in Obesity and Brain Function

Completed

Conditions studied: Obesity, Genetic Disorder, Mental Retardation, Developmental Delay

In brief

Background: \- Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause problems with appetite regulation. People with PWS often have behavior and thinking problems. People with MC4R mutations may have problems with attention. These problems may be related to Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain development. Researchers want to study people with PWS and MC4R mutations to see how BDNF is involved in these conditions. Specifically, body weight and brain function will be studied, and compared with healthy volunteers. Objectives: \- To study how BDNF affects body weight and brain function in people with PWS and MC4R mutations. Eligibility: * Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations. * Healthy volunteers of any age to act as control participants. Design: * Participants will be screened with a medical history and physical exam. Height, weight, and waist/hip circumferences will be measured. Blood samples will be taken for genetic and other tests. * Participants will fill out questionnaires about eating habits, pain perception, and sleep behavior. * Participants will keep a 3-day food diary to record all food and drinks eaten. * Tests and questionnaires will be given to study thinking, speech, movement, behavior, and mood. Some tests will be done on a computer; other tests will be on paper. Tests may also involve performing tasks with blocks and other objects. * Participants may have other tests as directed. These will include hot and cold sensitivity tests, imaging studies like x-rays, and measurements of body fat and water content. * Treatment will not be provided as part of this study.

Key facts

Study ID

NCT01517048

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

93

Starts

2012-01-09

Expected to finish

2014-12-12

Last updated by the study team

2019-12-17

Who can join

Age: any, up to 99. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subject Exclusion Criteria:
• For all subjects:
• Pregnancy
• Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study
• If age >12 months, greater than 2% body weight loss in preceding 6 months
• Anorexiant or weight loss medication use in preceding 6 months
• For control subjects:
• Chronic medical conditions anticipated to affect results or impede study participation
• Medication use will be reviewed on a case-by-case basis by the Principal Investigator to determine eligibility

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• University of Alberta — Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.