Obesity2aNCT00531505
Obesity and Memory, mRNA, Body Composition, Comorbidity Scale
An observational study of Obesity and Memory Deficits, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Memory Deficits
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subset population of LABS-1 study population.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.
- Briefly describe the purpose of this protocol. First purpose of the study is to understand the inheritance of morbid obesity.
- Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a research opportunity at the Bariatric Surgery Informational meetings.
- 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.
- If applicable, briefly describe survey/interview instruments used. Memory tests will be performed to assess cognition.
- 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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Obesity, Memory Deficits
- Keywords
- Obesity
- Medical subject headings
- Obesity, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Wolfe, Oregon Health and Science University
- Investigators
- Bruce M Wolfe, MD, Principal investigator, Professor of Surgery, Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531505
- Sponsor's protocol ID
- IRB00002571
- Acronym
- 2a
- Status last verified
- Oct 2015
- First submitted
- 18 Sep 2007
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbid Obesity and Memory, Visceral and Subcutaneous mRNA Analysis, Body Composition, and Comorbidity Scale.
- ClinicalTrials.gov ID
- NCT00531505
- Acronym / sponsor ID
- 2a / IRB00002571
- Conditions
- Obesity, Memory Deficits
- Keywords
- Obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Briefly describe the purpose of this protocol. First purpose of the study is to understand the inheritance of morbid obesity.
- Briefly summarize how participants are recruited. Volunteers will first learn of LABS-2a research opportunity at the Bariatric Surgery Informational meetings.
- 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.
- If applicable, briefly describe survey/interview instruments used. Memory tests will be performed to assess cognition.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subset population of LABS-1 study population.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Informed consent not obtained
- Prior bariatric surgery
- Unlikely to comply with follow-up protocol
- Unable to communicate with local study staff
- Extensive hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce M Wolfe, MD principal investigator
Professor of Surgery, Oregon Health & Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Memory Deficits, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Surgeon mistakenly removed liver and fat tissue from a non-LABS2a participant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.