An observational study in Diabetes and Weightloss, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Florida · Observational
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.
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 197 is below the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who are intending to have bariatric surgery for weight loss at local surgical centers or UFHEALTH \& Shands Hospital.
Procedure: Bariatric Surgery Candidates
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
Other: Non surgical/Community volunteers
Participants who are intending to have bariatric surgery for weight loss
Healthy adults with body mass index \>35 who will not undergo bariatric surgery for weight loss
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
Time frame: Change from baseline at 18 months
| Milestone | Bariatric Surgery Candidates | Non Surgical/Community Volunteers |
|---|---|---|
| Started | 150 | 47 |
| Completed | 76 | 29 |
| Not completed | 74 | 18 |
| Withdrew: Adverse event | 12 | 3 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Lost to follow-up | 24 | 9 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Protocol violation | 18 | 4 |
| Withdrew: Withdrawal by subject | 18 | 1 |
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
| Connectivity Fisher-z transformation | Bariatric Surgery Candidates | Non Surgical/Community Volunteers |
|---|---|---|
| Baseline - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | 0.10 ± 0.10 | 0.08 ± 0.09 |
| Follow-up - Seed (R Hippocampus) to cluster (MNI -44 -26 46) | 0.18 ± 0.13 | -0.01 ± 0.13 |
| Baseline - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | 0.09 ± 0.09 | 0.09 ± 0.10 |
| Follow-up - Seed (L Hippocampus) to cluster (MNI 16, -24, 56) | 0.16 ± 0.14 | -0.03 ± 0.14 |
| Baseline - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.07 ± 0.09 | 0.10 ± 0.09 |
| Follow-up - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24) | 0.21 ± 0.16 | 0.03 ± 0.14 |
| Baseline - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.05 ± 0.10 | 0.10 ± 0.07 |
| Follow-up - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30) | 0.16 ± 0.11 | 0.00 ± 0.10 |
| Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.12 ± 0.09 | 0.15 ± 0.08 |
| Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20) | 0.24 ± 0.09 | 0.09 ± 0.10 |
| Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.22 ± 0.12 | 0.20 ± 0.10 |
| Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52) | 0.34 ± 0.10 | 0.14 ± 0.12 |
| Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.14 ± 0.12 | 0.12 ± 0.11 |
| Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66) | 0.25 ± 0.13 | 0.06 ± 0.12 |
| Baseline - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.12 ± 0.11 | 0.11 ± 0.09 |
| Follow-up - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16) | 0.22 ± 0.09 | 0.01 ± 0.10 |
| Baseline - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.07 ± 0.10 | 0.10 ± 0.10 |
| Follow-up - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04) | 0.17 ± 0.10 | 0.00 ± 0.13 |
Collected over 18 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surgical Group | 2/150 (1.3%) | 5/150 (3.3%) | 11/150 (7.3%) |
| Control Group | 0/47 (0%) | 0/47 (0%) | 3/47 (6.4%) |
| Event | Surgical Group | Control Group |
|---|---|---|
| Post-surgical SymptomsGastrointestinal disorders | 3/150 | 0/47 |
| High BDIPsychiatric disorders | 2/150 | 0/47 |
| Event | Surgical Group | Control Group |
|---|---|---|
| MRI symptomsGeneral disorders | 4/150 | 2/47 |
| Blood draw problemsGeneral disorders | 3/150 | 1/47 |
| Survey Questions/Cognitive questionsSocial circumstances | 3/150 | 0/47 |
| Other tasksGeneral disorders | 1/150 | 0/47 |
| Age, Categorical(Participants) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 143 | 42 | 185 |
| >=65 years | 7 | 5 | 12 |
| Age, Continuous(years) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Mean | 42.54 ± 11.51 | 52.29 ± 12.51 | 44.86 ± 12.44 |
| Age, Customized(years) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Mean by intervention condition | 42.54 ± 11.51 | 52.29 ± 12.51 | 44.86 ± 12.44 |
| Sex: Female, Male(Participants) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Female | 118 | 32 | 150 |
| Male | 32 | 15 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 4 | 15 |
| Not Hispanic or Latino | 138 | 43 | 181 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 35 | 14 | 49 |
| White | 100 | 31 | 131 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 2 | 17 |
| Region of Enrollment(participants) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| United States | 150 | 47 | 197 |
| Age of study participants(years) | Bariatric Surgery Candidates | Non Surgical/Community Volunteers | Total |
|---|---|---|---|
| Mean | 42.54 ± 11.51 | 52.29 ± 12.51 | 44.86 ± 12.44 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Aug 2014 to primary completion in Nov 2022, 99 months.
Results were first posted in Dec 2024, 2 years 1 month after primary completion.
Of 630 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 130. This study's 99 months is above that.
Counting every sponsor, half of 771 studies reached it within 36 months; a quarter within 15 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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