Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT00531505
Status:
TERMINATED
Last Update Posted:
2015-10-16
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity and Memory, mRNA, Body Composition, Comorbidity Scale
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2a
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
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?: