Trial Outcomes & Findings for The WISE (Weightloss Intervention Surgical Effects) Brain Study (NCT NCT02137070)

Last Updated: 2024-12-05

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

197 participants

Primary outcome timeframe

Change from baseline at 18 months

Results posted on

2024-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	150	47
Overall Study COMPLETED	76	29
Overall Study NOT COMPLETED	74	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	12	3
Overall Study Death	2	0
Overall Study Lost to Follow-up	24	9
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	18	4
Overall Study Withdrawal by Subject	18	1

Baseline Characteristics

The WISE (Weightloss Intervention Surgical Effects) Brain Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bariatric Surgery Candidates n=150 Participants 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 n=47 Participants 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	Total n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	143 Participants n=5 Participants	42 Participants n=7 Participants	185 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	42.54 years STANDARD_DEVIATION 11.51 • n=5 Participants	52.29 years STANDARD_DEVIATION 12.51 • n=7 Participants	44.86 years STANDARD_DEVIATION 12.44 • n=5 Participants
Age, Customized Mean by intervention condition	42.54 years STANDARD_DEVIATION 11.51 • n=5 Participants	52.29 years STANDARD_DEVIATION 12.51 • n=7 Participants	44.86 years STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	32 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	15 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants	43 Participants n=7 Participants	181 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	14 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	100 Participants n=5 Participants	31 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	47 participants n=7 Participants	197 participants n=5 Participants
Age of study participants	42.54 years STANDARD_DEVIATION 11.51 • n=5 Participants	52.29 years STANDARD_DEVIATION 12.51 • n=7 Participants	44.86 years STANDARD_DEVIATION 12.44 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline at 18 months

Population: 37 individuals completed pre-surgery MRI at baseline and 18-month follow-up.

Outcome measures

Adverse Events

Surgical Group

Serious events: 5 serious events

Other events: 11 other events

Deaths: 2 deaths

Control Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Surgical Group n=150 participants at risk Participants that received surgery	Control Group n=47 participants at risk Participants that did not receive surgery
Gastrointestinal disorders Post-surgical Symptoms	2.0% 3/150 • 18 months Consistent with clinicaltrials.gov	0.00% 0/47 • 18 months Consistent with clinicaltrials.gov
Psychiatric disorders High BDI	1.3% 2/150 • 18 months Consistent with clinicaltrials.gov	0.00% 0/47 • 18 months Consistent with clinicaltrials.gov

Other adverse events

Other adverse events
Measure	Surgical Group n=150 participants at risk Participants that received surgery	Control Group n=47 participants at risk Participants that did not receive surgery
General disorders MRI symptoms	2.7% 4/150 • 18 months Consistent with clinicaltrials.gov	4.3% 2/47 • 18 months Consistent with clinicaltrials.gov
General disorders Blood draw problems	2.0% 3/150 • 18 months Consistent with clinicaltrials.gov	2.1% 1/47 • 18 months Consistent with clinicaltrials.gov
General disorders Other tasks	0.67% 1/150 • 18 months Consistent with clinicaltrials.gov	0.00% 0/47 • 18 months Consistent with clinicaltrials.gov
Social circumstances Survey Questions/Cognitive questions	2.0% 3/150 • 18 months Consistent with clinicaltrials.gov	0.00% 0/47 • 18 months Consistent with clinicaltrials.gov

Additional Information

Dr. Ronald Cohen

University of Florida

Phone: 352-273-6124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bariatric Surgery Candidates n=20 Participants 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 n=17 Participants 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
Change in BOLD fMRI Signal Baseline - Seed (R Hippocampus) to cluster (MNI -44 -26 46)	0.10 Connectivity Fisher-z transformation Standard Deviation 0.10	0.08 Connectivity Fisher-z transformation Standard Deviation 0.09
Change in BOLD fMRI Signal Follow-up - Seed (R Hippocampus) to cluster (MNI -44 -26 46)	0.18 Connectivity Fisher-z transformation Standard Deviation 0.13	-0.01 Connectivity Fisher-z transformation Standard Deviation 0.13
Change in BOLD fMRI Signal Baseline - Seed (L Hippocampus) to cluster (MNI 16, -24, 56)	0.09 Connectivity Fisher-z transformation Standard Deviation 0.09	0.09 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Follow-up - Seed (L Hippocampus) to cluster (MNI 16, -24, 56)	0.16 Connectivity Fisher-z transformation Standard Deviation 0.14	-0.03 Connectivity Fisher-z transformation Standard Deviation 0.14
Change in BOLD fMRI Signal Baseline - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24)	0.07 Connectivity Fisher-z transformation Standard Deviation 0.09	0.10 Connectivity Fisher-z transformation Standard Deviation 0.09
Change in BOLD fMRI Signal Follow-up - Seed (R Frontal Pole) to cluster (MNI 60, -26, 24)	0.21 Connectivity Fisher-z transformation Standard Deviation 0.16	0.03 Connectivity Fisher-z transformation Standard Deviation 0.14
Change in BOLD fMRI Signal Baseline - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30)	0.05 Connectivity Fisher-z transformation Standard Deviation 0.10	0.10 Connectivity Fisher-z transformation Standard Deviation 0.07
Change in BOLD fMRI Signal Follow-up - Seed (L Frontal Pole) to cluster (MNI 60, 08, -30)	0.16 Connectivity Fisher-z transformation Standard Deviation 0.11	0.00 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20)	0.12 Connectivity Fisher-z transformation Standard Deviation 0.09	0.15 Connectivity Fisher-z transformation Standard Deviation 0.08
Change in BOLD fMRI Signal Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI -66, -24, -20)	0.24 Connectivity Fisher-z transformation Standard Deviation 0.09	0.09 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52)	0.22 Connectivity Fisher-z transformation Standard Deviation 0.12	0.20 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 40, -22, 52)	0.34 Connectivity Fisher-z transformation Standard Deviation 0.10	0.14 Connectivity Fisher-z transformation Standard Deviation 0.12
Change in BOLD fMRI Signal Baseline - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66)	0.14 Connectivity Fisher-z transformation Standard Deviation 0.12	0.12 Connectivity Fisher-z transformation Standard Deviation 0.11
Change in BOLD fMRI Signal Follow-up - Seed (R Inferior Frontal Gyrus) to cluster (MNI 02, -38, 66)	0.25 Connectivity Fisher-z transformation Standard Deviation 0.13	0.06 Connectivity Fisher-z transformation Standard Deviation 0.12
Change in BOLD fMRI Signal Baseline - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16)	0.12 Connectivity Fisher-z transformation Standard Deviation 0.11	0.11 Connectivity Fisher-z transformation Standard Deviation 0.09
Change in BOLD fMRI Signal Follow-up - Seed (L Inferior Frontal Gyrus) to cluster (MNI 32, 14, -16)	0.22 Connectivity Fisher-z transformation Standard Deviation 0.09	0.01 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Baseline - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04)	0.07 Connectivity Fisher-z transformation Standard Deviation 0.10	0.10 Connectivity Fisher-z transformation Standard Deviation 0.10
Change in BOLD fMRI Signal Follow-up - Seed (Anterior Cingulate) to cluster (MNI 60, -06, -04)	0.17 Connectivity Fisher-z transformation Standard Deviation 0.10	0.00 Connectivity Fisher-z transformation Standard Deviation 0.13