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The WISE (Weightloss Intervention Surgical Effects) Brain Study (WISEBrain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137070
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment
Diabetes Weightloss Procedure: Bariatric Surgery Candidates Other: Non surgical/Community volunteers

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.


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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Obesity and Type 2 Diabetes, Bariatric Surgery Effects on Brain Function
Study Start Date : August 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bariatric Surgery Candidates
Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH & Shands Hospital.
Procedure: 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
Other: Non surgical/Community volunteers
Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss




Primary Outcome Measures :
  1. Change in BOLD fMRI signal [ Time Frame: Change from baseline at 18 months ]
    Brain activation changes will change in the frontal cortex and hippocampus.


Biospecimen Retention:   Samples With DNA
Blood samples will be retained for biomarker analysis.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT02137070


Contacts
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Contact: Alexa Study Coordinator 352-294-5837 wisestudy@phhp.ufl.edu

Locations
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United States, Florida
University of Florida - College of Public Health and Health Professions Recruiting
Gainesville, Florida, United States, 32611
Contact: Alex Study Coordinator    352-294-5837    wisestudy@phhp.ufl.edu   
Sub-Investigator: Kenneth Cusi, MD         
Sub-Investigator: Stephen Anton, PhD         
Sub-Investigator: Michael Marsiske, PhD         
Sub-Investigator: Adam J. Woods, PhD         
Sub-Investigator: Song Lai, PhD         
Sub-Investigator: Christiaan Leeuwenburgh, PhD         
Sub-Investigator: Pahor Marco, MD         
Sub-Investigator: Catherine Price, PhD         
Sub-Investigator: Christina McCrae, PhD         
Sub-Investigator: Erik Middlebrooks, MD         
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ronald A Cohen, PHD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02137070     History of Changes
Other Study ID Numbers: IRB201400034-N
1R01DK099334-01A1 ( U.S. NIH Grant/Contract )
OCR15981 ( Other Identifier: Universiy of Florida )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Weightloss and brain function
Effects of bariatric surgery on brain function
Reduced glucose insulin changes and brain function
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms