NCT02137070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 5, 2024

Completed
Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

8.3 years

First QC Date

May 9, 2014

Results QC Date

July 18, 2024

Last Update Submit

November 20, 2024

Conditions

DiabetesWeightloss

Keywords

Weightloss and brain functionEffects of bariatric surgery on brain functionReduced glucose insulin changes and brain function

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from baseline at 18 months

Study Arms (2)

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

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

Interventions

Bariatric Surgery CandidatesPROCEDURE

Participants who are intending to have bariatric surgery for weight loss

Bariatric Surgery Candidates
Non surgical/Community volunteersOTHER

Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss

Non surgical/Community volunteers

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida - College of Public Health and Health Professions

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • 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.

    PMID: 31116012DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained for biomarker analysis.

MeSH Terms

Conditions

Diabetes MellitusWeight Loss

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ronald Cohen
Organization
University of Florida
roncohen@ufl.edu
352-273-6124

Study Officials

  • Ronald A Cohen, PHD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

December 5, 2024

Results First Posted

December 5, 2024

Record last verified: 2024-11

Locations

US(1)