Obesity Clinical Trial
Official title:
Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.
1. Briefly describe the purpose of this protocol. First purpose of the study is to
understand the inheritance of morbid obesity.
2. Briefly summarize how participants are recruited. Volunteers will first learn of
LABS-2a research opportunity at the Bariatric Surgery Informational meetings.
3. Briefly describe the procedures subjects will undergo.
Participants will be asked to complete a set of memory tests. Fat and Liver samples
will be removed during their weight loss surgery, specifically for this research study.
4. If applicable, briefly describe survey/interview instruments used. Memory tests will be
performed to assess cognition.
5. Briefly describe how the data will be analyzed to address the purpose of the protocol.
The memory test data collected and compared against well established norms. Tissue samples
will stored in a repository to be genetically studied for an indefinite amount of time.
Genetic studies will be related to the disease of obesity and associated comorbidities
brought on by the disease.
1. Briefly describe the purpose of this protocol. First purpose of the study is to
understand the inheritance of morbid obesity. If a gene or genes cause morbid obesity
can be found, the diagnosis and treatment of morbid obesity may be improved. Second
purpose is to learn more about the effects of weight loss on dementia, body
composition, and comorbidity.
2. Briefly summarize how participants are recruited. Volunteers will first learn of
LABS-2a research opportunity at the Bariatric Surgery Informational meetings. Subjects
who express interest, will be screened through an IRB-approved informal telephone
interview. If no exclusion criteria are identified, volunteers will be asked to provide
IRB-approved consent. Recruitment will occur irrespective of race, religion or color.
3. Briefly describe the procedures subjects will undergo. Participants will be asked to
complete a set of memory tests. These memory tests will be recorded on audio tape.
BodPod will be used to measure their muscle, bone, and fat. The BodPod is an upright
capsule that will enclose around a subject completely. BodPod uses the movement of air
to measure muscle, and fat volumes. Participation in the memory testing portion and the
BodPod portion of the research is optional. Fat and Liver samples will be removed
during their weight loss surgery, specifically for this research study.
4. If applicable, briefly describe survey/interview instruments used. Memory tests will be
performed to assess cognition. The Wechsler Memory Scale-Third Edition (WMS-III) and
the Mini Memory State Examination (MMSE) will be the validated memory tests used. The
WMS-III tests logical memory by having subjects recall short stories that were just
read to them. The MMSE involves performing a set of requests that test orientation to
time and place, immediate recall, short term verbal memory, calculation, language and
construct ability.
5. Briefly describe how the data will be analyzed to address the purpose of the protocol.
The memory test data collected and compared against well established norms. Tissue samples
will stored in a repository to be genetically studied for an indefinite amount of time.
Genetic studies will be related to the disease of obesity and associated comorbidities
brought on by the disease.
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Observational Model: Cohort, Time Perspective: Prospective
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