Trial Outcomes & Findings for Longitudinal Phenotyping of Bariatric Surgery Patients (NCT NCT02421055)
NCT ID: NCT02421055
Last Updated: 2020-11-06
Results Overview
Participants with HbA1c \<6% (42mmol/mol), off anti-diabetic medication, at 3 months
Recruitment status
COMPLETED
Target enrollment
158 participants
Primary outcome timeframe
3 months
Results posted on
2020-11-06
Participant Flow
Some participants consented to give serum samples only, others were able to give complete sets of serum, 24-hour urine and stool, as detailed below.
Participant milestones
| Measure |
Pre-operative Only
Recruited patients that did not undergo RYGB or VSG procedures
|
Roux-en-Y Gastric Bypass (RYGB)
Participants who underwent RYGB procedure
|
Vertical Sleeve Gastrectomy (VSG)
Participants who underwent VSG procedure
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
50
|
74
|
|
Overall Study
Pre-operative Serum Sample (Minimum)
|
34
|
50
|
74
|
|
Overall Study
Pre-operative Complete Sample Set
|
23
|
22
|
36
|
|
Overall Study
Post-operative Serum Sample (Minimum)
|
0
|
23
|
26
|
|
Overall Study
Post-operative Complete Sample Set
|
0
|
13
|
14
|
|
Overall Study
COMPLETED
|
0
|
50
|
74
|
|
Overall Study
NOT COMPLETED
|
34
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=50 Participants
50 participants gave pre-operative serum samples prior to undergoing RYGB. 23 participants underwent RYGB and gave serum samples pre and 3-months post-operatively.
13 of these gave complete sample sets of serum, 24-hour urine and stool pre and 3-months post-operation.
|
Vertical Sleeve Gastrectomy (VSG)
n=74 Participants
74 participants gave pre-operative serum samples prior to undergoing VSG. 26 participants underwent VSG and gave serum samples pre and 3-months post-operatively.
14 of these gave complete sample sets of serum, 24-hour urine and stool pre and 3-months post-operation.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.54 years
STANDARD_DEVIATION 11.04 • n=50 Participants
|
44.01 years
STANDARD_DEVIATION 11.91 • n=74 Participants
|
45.03 years
STANDARD_DEVIATION 11.59 • n=124 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=50 Participants
|
49 Participants
n=74 Participants
|
90 Participants
n=124 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=50 Participants
|
25 Participants
n=74 Participants
|
34 Participants
n=124 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
50 participants
n=50 Participants
|
74 participants
n=74 Participants
|
124 participants
n=124 Participants
|
|
Weight (Kg)
|
120.86 Kg
STANDARD_DEVIATION 20.17 • n=50 Participants
|
133.6 Kg
STANDARD_DEVIATION 30.35 • n=74 Participants
|
128.14 Kg
STANDARD_DEVIATION 27.29 • n=124 Participants
|
|
BMI (kg/m2)
|
44.43 Kg/m2
STANDARD_DEVIATION 5.69 • n=50 Participants
|
47.12 Kg/m2
STANDARD_DEVIATION 8.99 • n=74 Participants
|
46.03 Kg/m2
STANDARD_DEVIATION 7.91 • n=124 Participants
|
|
Diabetes Status
Type 2 Diabetes (T2D)
|
27 Participants
n=50 Participants
|
24 Participants
n=74 Participants
|
51 Participants
n=124 Participants
|
|
Diabetes Status
Impaired Glucose Tolerence (IGT)
|
7 Participants
n=50 Participants
|
13 Participants
n=74 Participants
|
20 Participants
n=124 Participants
|
|
Diabetes Status
Non-diabetic
|
16 Participants
n=50 Participants
|
37 Participants
n=74 Participants
|
53 Participants
n=124 Participants
|
|
HBA1c
|
52.24 mmols/mol
STANDARD_DEVIATION 17.66 • n=50 Participants
|
45.41 mmols/mol
STANDARD_DEVIATION 12.82 • n=74 Participants
|
48.16 mmols/mol
STANDARD_DEVIATION 15.27 • n=124 Participants
|
|
Metformin use
|
26 Participants
n=50 Participants
|
22 Participants
n=74 Participants
|
48 Participants
n=124 Participants
|
|
Insulin use
|
10 Participants
n=50 Participants
|
5 Participants
n=74 Participants
|
15 Participants
n=124 Participants
|
|
Duration of T2D (years)
|
7.96 years
STANDARD_DEVIATION 7.03 • n=27 Participants • T2D participants only
|
7.75 years
STANDARD_DEVIATION 8.47 • n=24 Participants • T2D participants only
|
7.86 years
STANDARD_DEVIATION 7.66 • n=51 Participants • T2D participants only
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants with complete follow up data
Participants with HbA1c \<6% (42mmol/mol), off anti-diabetic medication, at 3 months
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=18 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=16 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Number of Participants With Complete Diabetes Remission at 3 Months
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants with complete follow up data
HbA1c \<6.5% (48mmol/mol), off anti-diabetic medication, at 3 months. (Includes participants with complete remission).
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=18 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=16 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Partial Diabetes Remission
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants attending follow up
Reduction in HbA1c at 3 months
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=44 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=67 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
HbA1c Improvement
|
12.0 mmols/mol
Standard Deviation 11.98
|
7.53 mmols/mol
Standard Deviation 10.18
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants attending follow up
Weight loss at 3 months
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=44 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=67 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Weight Loss
|
24.13 Kg/m2
Standard Deviation 9.13
|
24.00 Kg/m2
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants attending follow up
BMI reduction at 3 months
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=44 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=67 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
BMI Reduction
|
8.87 Kg/m2
Standard Deviation 2.99
|
8.51 Kg/m2
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with complete follow up data
HbA1c \<6% (42mmol/mol), off anti-diabetic medication, at 1 year
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=15 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=12 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Complete Diabetes Remission
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with complete follow up data
HbA1c \<6.5% (48mmol/mol), off anti-diabetic medication, at 1 year. (Includes participants with complete diabetes remission).
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=15 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=12 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Partial Diabetes Remission
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants attending follow up
Reduction in HbA1c at 1 year
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=36 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=57 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
HbA1c Improvement
|
13.72 mmols/mol
Standard Deviation 13.71
|
6.88 mmols/mol
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants attending follow up
Weight loss at 1 year
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=36 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=57 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
Weight Loss
|
37.53 Kg
Standard Deviation 11.36
|
35.23 Kg
Standard Deviation 12.98
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants attending follow up
BMI reduction at 1 year
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass
n=36 Participants
Participants who underwent Roux-en-Y Gastric Bypass
|
Vertical Sleeve Gastrectomy
n=57 Participants
Participants who underwent Vertical Sleeve Gastrectomy
|
|---|---|---|
|
BMI Reduction
|
13.8 Kg/m2
Standard Deviation 3.69
|
13.02 Kg/m2
Standard Deviation 5.54
|
Adverse Events
Pre-operative Samples Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Roux-en-Y Gastric Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vertical Sleeve Gastrectomy
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