Trial Outcomes & Findings for An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery (NCT NCT02067585)
NCT ID: NCT02067585
Last Updated: 2017-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
0 minutes
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
LAGB
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
no-operated
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery
Baseline characteristics by cohort
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9 • n=5 Participants
|
48 years
STANDARD_DEVIATION 10 • n=7 Participants
|
46 years
STANDARD_DEVIATION 9 • n=5 Participants
|
46 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
weight current
|
108.7 kg
STANDARD_DEVIATION 26.4 • n=5 Participants
|
108.5 kg
STANDARD_DEVIATION 21.1 • n=7 Participants
|
115.8 kg
STANDARD_DEVIATION 17.1 • n=5 Participants
|
111.0 kg
STANDARD_DEVIATION 21.7 • n=4 Participants
|
|
waist circumference
|
118 cm
STANDARD_DEVIATION 16 • n=5 Participants
|
121 cm
STANDARD_DEVIATION 16 • n=7 Participants
|
122 cm
STANDARD_DEVIATION 8 • n=5 Participants
|
121 cm
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Type 2 diabetes
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 minutesOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Triglycerides Post-prandial
|
95 mmol/L
Standard Deviation 64
|
71 mmol/L
Standard Deviation 53
|
134 mmol/L
Standard Deviation 92
|
PRIMARY outcome
Timeframe: 30 minutesOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Triglycerides
|
93 mmol/L
Standard Deviation 64
|
85 mmol/L
Standard Deviation 71
|
115 mmol/L
Standard Deviation 79
|
PRIMARY outcome
Timeframe: 90 minutesOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Triglyceride
|
123 mmol/L
Standard Deviation 75
|
87 mmol/L
Standard Deviation 61
|
174 mmol/L
Standard Deviation 101
|
PRIMARY outcome
Timeframe: 4 hoursOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Triglyceride
|
124 mmol/L
Standard Deviation 93
|
72 mmol/L
Standard Deviation 63
|
182 mmol/L
Standard Deviation 150
|
PRIMARY outcome
Timeframe: 6 hoursOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Triglyceride
|
103 mmol/L
Standard Deviation 67
|
59 mmol/L
Standard Deviation 51
|
123 mmol/L
Standard Deviation 87
|
SECONDARY outcome
Timeframe: 0 minuteOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Blood Glucose
|
4.8 mmol/L
Standard Deviation 0.4
|
4.7 mmol/L
Standard Deviation 0.4
|
5.5 mmol/L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 30 minutesOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Glucose
|
5.3 mmol/L
Standard Deviation 0.7
|
7.4 mmol/L
Standard Deviation 1.6
|
6.2 mmol/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 90 minutesOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Glucose
|
5.3 mmol/L
Standard Deviation 0.7
|
3.8 mmol/L
Standard Deviation 0.8
|
5.9 mmol/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 4 hoursOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Glucose
|
4.7 mmol/L
Standard Deviation 0.5
|
4.6 mmol/L
Standard Deviation 0.4
|
5.1 mmol/L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 hoursOutcome measures
| Measure |
LAGB
n=16 Participants
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 Participants
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 Participants
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Glucose
|
4.8 mmol/L
Standard Deviation 0.9
|
4.7 mmol/L
Standard Deviation 0.3
|
4.9 mmol/L
Standard Deviation 0.4
|
Adverse Events
LAGB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LRYGB
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LAGB
n=16 participants at risk
Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
LRYGB
n=16 participants at risk
Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
Control
n=16 participants at risk
Standardized Lipid meals will be served to the no-operated patients.
Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
|
|---|---|---|---|
|
Gastrointestinal disorders
Mild nausea
|
0.00%
0/16
|
12.5%
2/16
|
6.2%
1/16
|
|
General disorders
Mild headache
|
0.00%
0/16
|
6.2%
1/16
|
6.2%
1/16
|
|
Endocrine disorders
Blood Glucose < 3mmol/L (90 mins post-meal)
|
0.00%
0/16
|
12.5%
2/16
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place