Brain-Derived Neurotrophic Factor in Obesity and Brain Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01517048|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : September 18, 2018
- 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.
- To study how BDNF affects body weight and brain function in people with PWS and MC4R mutations.
- Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations.
- Healthy volunteers of any age to act as control participants.
- 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.
|Condition or disease|
|Obesity Genetic Disorder Mental Retardation Developmental Delay|
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||Brain-Derived Neurotrophic Factor in Obesity and Neurocognitive Function|
|Study Start Date :||January 9, 2012|
|Study Completion Date :||December 12, 2014|
- Serum brain-derived neurotrophic factor concentration
- Body Composition, Cognitive Function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517048
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|University of Alberta|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|