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

This study has suspended participant recruitment.
(Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant)
Sponsor:
Collaborator:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00531505
First received: September 18, 2007
Last updated: May 2, 2008
Last verified: May 2008
  Purpose
  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.


Condition
Memory
Obesity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Estimated Enrollment: 300
Study Start Date: March 2007
Estimated Study Completion Date: August 2008
Groups/Cohorts
2a
Morbid Obese individuals undergoing bariatric surgery (i.e. Laparoscopic Banding, Gastric Bypass).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00531505     History of Changes
Other Study ID Numbers: IRB00002571
Study First Received: September 18, 2007
Last Updated: May 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Memory
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014