DiabetesWISEBrainNCT02137070
The WISE (Weightloss Intervention Surgical Effects) Brain Study
An observational study of Diabetes and Weightloss, run by University of Florida at 1 site in United States.
Trial summary
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Weightloss
- What is being tested?
- Bariatric Surgery Candidates and Non surgical/Community volunteers
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential bariatric surgery patients will have study specific information made available to them for their consideration at the bariatric or diabetes clinics at UFHealth \& Shands Hospital, or at other community locations. Flyers will be posted in many community advertising locations in the North Florida region. Prospective participants must live in Gainesville, FL or the surrounding areas to be eligible.
Who may be able to join
- Body Mass Index >35
- Diabetes or no diabetes
- Compatible with MRI Scanning
- Willing to give a small blood sample on 3 occasions
- Capable of providing informed consent
Who cannot join
- Prior neurological disorder
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida - College of Public Health and Health Professions
Gainesville, Florida, 32611
About this study
Official title: Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
Read the detailed description
There will be two groups of people studied:
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
- Diabetes, Weightloss
- Being tested
- Bariatric Surgery Candidates, Non surgical/Community volunteers
- Keywords
- Weightloss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function
- Medical subject headings
- Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Surgery CandidatesProcedure or surgery
Participants who are intending to have bariatric surgery for weight loss
Non surgical/Community volunteersOther
Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery Candidates | Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital. Receives: Procedure: Bariatric Surgery Candidates | |
| Non surgical/Community volunteers | Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss Receives: Other: Non surgical/Community volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOLD fMRI Signal
Brain activation changes will change in the frontal cortex and hippocampus.
- z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions
- a value of < 0 suggests a weakening of the connections between brain areas; and a value of > 0 suggests a strengthening of the connections between brain areas
- A value of r=0 indicates that two brain regions were functionally disconnected
Measured: Change from baseline at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2022
- Study completionNov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald A Cohen, PHD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137070
- Sponsor's protocol ID
- IRB201400034-N
- Other IDs
- 1R01DK099334-01A1, OCR15981
- Acronym
- WISEBrain
- Status last verified
- Nov 2024
- First submitted
- 9 May 2014
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31116012
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function
- ClinicalTrials.gov ID
- NCT02137070
- Acronym / sponsor ID
- WISEBrain / IRB201400034-N
- Conditions
- Diabetes, Weightloss
- Keywords
- Weightloss and brain function, Effects of bariatric surgery on brain function, Reduced glucose insulin changes and brain function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2014 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. The study does NOT cover any costs associated with bariatric surgery.
Detailed description
There will be two groups of people studied:
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery Candidates | – | Procedure: Bariatric Surgery CandidatesParticipants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital. |
| Non surgical/Community volunteers | – | Other: Non surgical/Community volunteersHealthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential bariatric surgery patients will have study specific information made available to them for their consideration at the bariatric or diabetes clinics at UFHealth \& Shands Hospital, or at other community locations. Flyers will be posted in many community advertising locations in the North Florida region. Prospective participants must live in Gainesville, FL or the surrounding areas to be eligible.
Key inclusion criteria (5 listed)
- Body Mass Index >35
- Diabetes or no diabetes
- Compatible with MRI Scanning
- Willing to give a small blood sample on 3 occasions
- Capable of providing informed consent
Key exclusion criteria (6 listed)
- Prior neurological disorder
- Mini Mental Status Exam score
- Major psychiatric disturbance (schizophrenia, chronic intractable depression,
- Coronary revascularization, peripheral vascular disease
- Severe cardio vascular disease history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric Surgery CandidatesParticipants who are intending to have bariatric surgery for weight loss | Procedure or surgery | Bariatric Surgery Candidates |
| Non surgical/Community volunteersHealthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss | Other | Non surgical/Community volunteers |
Primary outcome
Change in BOLD fMRI Signal
Time frame: Change from baseline at 18 months
Brain activation changes will change in the frontal cortex and hippocampus. * z-score is a transformation of the Pearson's (r) correlation coefficient of the BOLD timeseries between two brain regions * a value of < 0 suggests a weakening of the connections between brain areas; and a value of > 0 suggests a strengthening of the connections between brain areas * A value of r=0 indicates that two brain regions were functionally disconnected
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31116012Fernando 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.
- Individual participant dataSharing planned: Undecided
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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.
Ronald A Cohen, PHD principal investigator
University of Florida
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 Diabetes and Weightloss, run by University of Florida 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 5 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change in BOLD fMRI Signal (time frame: Change from baseline at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137070, which also lists 1 linked publication.
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 5 Dec 2024.