Status:
COMPLETED
Brain-Derived Neurotrophic Factor in Obesity and Brain Function
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Genetic Disorder
Eligibility:
All Genders
Up to 99 years
Brief Summary
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. P...
Detailed Description
Brain-derived neurotrophic factor (BDNF) is a protein that is important in nervous system development and function. BDNF also appears to function downstream of the leptin-melanocortin signaling pathwa...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject
- For PWS subjects: We will enroll 75 subjects of all ages who have diagnosis of PWS confirmed by chromosome analysis (i.e. interstitial deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other chromosome 15 abnormalities). Our goal is to have 25 infants, 25 non-obese, and 25 obese subjects in order to assess the different phases associated with PWS. Subjects receiving growth hormone therapy may enroll if the dose has been stable for the preceding 6 months.
- For MC4R subjects: We will screen up to 200 subjects for mutations of MC4R and enroll 50 subjects of all ages who have diagnosis of homozygous or heterozygous MC4R mutation confirmed by sequencing of the MC4R gene. Both functional-altering (N=25) and non-pathologic (N=25) mutations will be included.
- For control subjects: We will enroll 125 subjects of all ages who match with PWS or MC4R subjects by age (plus-minus 10%), sex, race, and BMI percentile (plus-minus10%).
- EXCLUSION CRITERIA:
- Subject
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2014
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01517048
Start Date
January 9 2012
End Date
December 12 2014
Last Update
December 17 2019
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
University of Alberta
Alberta, Canada