Obesity Clinical Trial
— 2aOfficial 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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon - Previous enrollment in LABS-1 and LABS-2 Exclusion Criteria: - Informed consent not obtained - Prior bariatric surgery - Unlikely to comply with follow-up protocol - Unable to communicate with local study staff - Extensive hearing impairment - Medical conditions known to impact cognitive performance, including past or present history of traumatic brain injury or neurological disorder. - Non-English speaking - Inability to withhold caffeine and nicotine 2 hours before each visit, and alcohol 12 hours before each visit. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
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