The WISE (Weightloss Intervention Surgical Effects) Brain Study
NCT ID: NCT02137070
Last Updated: 2024-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
197 participants
OBSERVATIONAL
2014-08-31
2022-11-30
Brief Summary
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Detailed Description
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One group has chosen (independently of this research study) to have weight loss surgery to help them lose weight.
Another group will not choose to have any weight loss surgery. All research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will have an MRI Brain Scan at those same times also to look at changes in the structure and function of the brain tissue.
Blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Bariatric Surgery Candidates
Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital.
Bariatric Surgery Candidates
Participants who are intending to have bariatric surgery for weight loss
Non surgical/Community volunteers
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Non surgical/Community volunteers
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Interventions
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Bariatric Surgery Candidates
Participants who are intending to have bariatric surgery for weight loss
Non surgical/Community volunteers
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Eligibility Criteria
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Inclusion Criteria
* Diabetes or no diabetes
* Compatible with MRI Scanning
* Willing to give a small blood sample on 3 occasions
* Capable of providing informed consent
Exclusion Criteria
* Mini Mental Status Exam score
* Major psychiatric disturbance (schizophrenia, chronic intractable depression,
* Coronary revascularization, peripheral vascular disease
* Severe cardio vascular disease history
* Unstable medical conditions (cancer)
20 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Ronald A Cohen, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida - College of Public Health and Health Professions
Gainesville, Florida, United States
Countries
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References
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Fernando HJ, Cohen RA, Gullett JM, Friedman J, Ayzengart A, Porges E, Woods AJ, Gunstad J, Ochoa CM, Cusi K, Gonzalez-Louis R, Donahoo WT. Neurocognitive Deficits in a Cohort With Class 2 and Class 3 Obesity: Contributions of Type 2 Diabetes and Other Comorbidities. Obesity (Silver Spring). 2019 Jul;27(7):1099-1106. doi: 10.1002/oby.22508. Epub 2019 May 22.
Provided Documents
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Document Type: Study Protocol: Protocol Document
Document Type: Study Protocol and Informed Consent Form: ICF Document
Other Identifiers
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OCR15981
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201400034-N
Identifier Type: -
Identifier Source: org_study_id