Trial Outcomes & Findings for A Cohort Study of Weight Loss and Gliosis (NCT NCT03578887)
NCT ID: NCT03578887
Last Updated: 2025-09-04
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
During 6 Month Behavioral Weight Loss Program
Results posted on
2025-09-04
Participant Flow
Participant milestones
| Measure |
Lifestyle Cohort
Participants Undergoing Behavioral Weight Loss Program
Behavioral Weight Loss Program: Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
|
Surgical Cohort
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy: Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
|
Healthy Weight Control Cohort
Healthy Weight Controls With No Intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
13
|
27
|
|
Overall Study
COMPLETED
|
52
|
9
|
21
|
|
Overall Study
NOT COMPLETED
|
20
|
4
|
6
|
Reasons for withdrawal
| Measure |
Lifestyle Cohort
Participants Undergoing Behavioral Weight Loss Program
Behavioral Weight Loss Program: Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
|
Surgical Cohort
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy: Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
|
Healthy Weight Control Cohort
Healthy Weight Controls With No Intervention
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
13
|
1
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
A Cohort Study of Weight Loss and Gliosis
Baseline characteristics by cohort
| Measure |
Lifestyle Cohort
n=72 Participants
Participants Undergoing Behavioral Weight Loss Program
Behavioral Weight Loss Program: Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
|
Surgical Cohort
n=13 Participants
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy: Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
|
Healthy Weight Control Cohort
n=27 Participants
Healthy Weight Controls With No Intervention
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
112 participants
n=4 Participants
|
|
Weight
|
105.4 kilograms
STANDARD_DEVIATION 17.4 • n=5 Participants
|
105.0 kilograms
STANDARD_DEVIATION 11.9 • n=7 Participants
|
65.0 kilograms
STANDARD_DEVIATION 10.0 • n=5 Participants
|
95.5 kilograms
STANDARD_DEVIATION 23.1 • n=4 Participants
|
|
BMI
|
37.3 kg/m2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
40.4 kg/m2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
22.2 kg/m2
STANDARD_DEVIATION 1.8 • n=5 Participants
|
34.0 kg/m2
STANDARD_DEVIATION 8.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: During 6 Month Behavioral Weight Loss ProgramPopulation: This analysis considers participants with available weight data at baseline and 6-months (end of treatment).
Outcome measures
| Measure |
Lifestyle Cohort
n=56 Participants
Participants Undergoing Behavioral Weight Loss Program
Behavioral Weight Loss Program: Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
|
Surgical Cohort
n=11 Participants
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy: Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
|
Healthy Weight Control Cohort
n=18 Participants
Healthy Weight Controls With No Intervention
|
|---|---|---|---|
|
Percent Change in Weight From Baseline
|
-6.1 percentage change from baseline
Standard Error 0.8
|
-21.2 percentage change from baseline
Standard Error 1.9
|
1.2 percentage change from baseline
Standard Error 0.7
|
PRIMARY outcome
Timeframe: During 12-Month Follow-Up After InterventionPopulation: This analysis considers participants with available data at the end of treatment visit (6-month visit) and 12-months later (18-month visit).
Change in Weight (kg) during 12 month follow-up period
Outcome measures
| Measure |
Lifestyle Cohort
n=45 Participants
Participants Undergoing Behavioral Weight Loss Program
Behavioral Weight Loss Program: Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
|
Surgical Cohort
n=9 Participants
Participants Scheduled for Roux-en-Y Gastric Bypass Surgery
Roux-en-Y Gastric Bypass or Sleeve Gastrectomy: Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
|
Healthy Weight Control Cohort
n=16 Participants
Healthy Weight Controls With No Intervention
|
|---|---|---|---|
|
Weight Regain
|
0.7 change in kg during 12M follow up
Standard Error 2.1
|
-1.8 change in kg during 12M follow up
Standard Error 2.2
|
0.1 change in kg during 12M follow up
Standard Error 0.7
|
Adverse Events
Lifestyle Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgical Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Weight Control Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place