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Obesity and Memory, mRNA, Body Composition, Comorbidity Scale (2a)

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ClinicalTrials.gov Identifier: NCT00531505
Recruitment Status : Terminated (Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant)
First Posted : September 19, 2007
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Bruce Wolfe, Oregon Health and Science University

Study Description
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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.


Condition or disease
Obesity Memory Deficits

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.


Study Design
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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.
Study Start Date : March 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
2a
Morbid Obese individuals undergoing bariatric surgery (i.e. Laparoscopic Banding, Gastric Bypass). These individuals are a subset population of the greater Longitudinal Assessment of Bariatric Surgery (LABS-1) study population. This subpopulation engaged in memory tests as well as tissue extraction.


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Liver and fatty samples were voluntarily given by participant consent.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subset population of LABS-1 study population.
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531505


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Bruce M Wolfe, MD Professor of Surgery, Oregon Health & Science University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bruce Wolfe, Professor of Surgery, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00531505     History of Changes
Other Study ID Numbers: IRB00002571
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Bruce Wolfe, Oregon Health and Science University:
Obesity

Additional relevant MeSH terms:
Obesity
Memory Disorders
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases