Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01517048
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2012-01-24
Brief Title:
Brain-Derived Neurotrophic Factor in Obesity and Brain Function
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Brain-Derived Neurotrophic Factor in Obesity and Neurocognitive Function
Status:
COMPLETED
Status Verified Date:
2014-12-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 waisthip 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
- 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 waisthip 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
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 pathway to control appetite In both animals and humans diminished BDNF function is associated with hyperphagia obesity and neurocognitive deficits We propose to study BDNF in two hyperphagic disorders Prader-Willi syndrome and MC4R function-altering mutations We hypothesize that patients with PWS may have increased BDNF during infancy followed by a decline in BDNF that precedes the onset of hyperphagia and persists after the onset of obesity We hypothesize that patients with MC4R mutations will have decreased BDNF the severity of which will be associated with the degree of MC4R functional loss caused by the specific mutations in each individual To test these hypotheses we wish to conduct cross-sectional studies to evaluate serum BDNF concentrations metabolism body composition and neurocognition in subjects with PWS subjects with MC4R mutations and control subjects matched for age sex race and BMI If alterations in BDNF are found to be associated with PWS andor MC4R mutations these investigations could lead to future studies of BDNF receptor agonists as mechanism-specific pharmacologic therapy for hyperphagia and obesity in PWS and MC4R mutations or BDNF receptor antagonists for failure-to-thrive in neonatal PWS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-CH-0051 | None | None | None |