Trial Outcomes & Findings for Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass (NCT NCT02144597)
NCT ID: NCT02144597
Last Updated: 2021-03-18
Results Overview
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
at 2 weeks or 6 weeks depending on group
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
4
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Baseline characteristics by cohort
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=9 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=8 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=7 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
46 years
n=7 Participants
|
40 years
n=5 Participants
|
42 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: at 2 weeks or 6 weeks depending on groupPopulation: The numbers are not the same because depending on the variable measured (some might have missing data) and its timepoint (baseline, visit 2, 3 or 4), there are more or less patients. For example, 29 were initially enrolled, 24 had data available after the baseline visit, 21 had MRI liver data at visit 3 (1 motnh post surgery) and 16 had MRI liver data at 6 months.
Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy
Outcome measures
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=9 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=8 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=6 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
|
40.0 percentage of change in IHCL
Standard Error 7.1
|
67.4 percentage of change in IHCL
Standard Error 9.1
|
0.1 percentage of change in IHCL
Standard Error 8.3
|
SECONDARY outcome
Timeframe: at 1-month following Roux-en-Y gastric bypassIntra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass
Outcome measures
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=8 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=7 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=6 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
|
31.8 percentage change in IHCL
Standard Error 13.4
|
57.8 percentage change in IHCL
Standard Error 11.9
|
26.4 percentage change in IHCL
Standard Error 15.1
|
SECONDARY outcome
Timeframe: at 6 months following Roux-en-Y gastric bypassIntra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass
Outcome measures
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=4 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=6 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=6 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
|
69.8 percentage change in IHCL
Standard Error 16.5
|
88.1 percentage change in IHCL
Standard Error 3.5
|
83.0 percentage change in IHCL
Standard Error 8.3
|
SECONDARY outcome
Timeframe: at the time of surgeryComplexity of surgery will be assessed by the surgeon at the time of surgery (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group) The complexity of the surgery was assessed through a score on a complexity scale based on questionnaires previously published by Anders Thorell"s and David Edholm"s groups (Edholm et al., 2011, Van Nieuwenhove et al., 2011). The scores (1-5) for 7 variables: exposure, bleeding, difficulty in dissection, difficulty in reconstruction, surgical judgment, technical demand and psychological stress were combined into a complexity of surgery score with a minimum of 7 (very little complexity) and a maximum of 35 (very high complexity).
Outcome measures
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=7 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=6 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=5 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Complexity of Surgery
|
12 scores on a scale
Standard Error 5
|
13 scores on a scale
Standard Error 3
|
12 scores on a scale
Standard Error 4
|
SECONDARY outcome
Timeframe: at the time of surgeryThe operative time will be recorded at the time of surgery by the operating surgeon (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group)
Outcome measures
| Measure |
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
n=7 Participants
A 2-week liquid formula low-calorie diet (LCD) will be administered for 2 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
|
6-week LCD
n=6 Participants
A 6-week liquid formula low-calorie diet (LCD) will be administered for 6 weeks prior to Roux-en-Y gastric bypass. The diet will provide 800kcal per day in the form of powdered milkshakes and soups
Liquid formula low-calorie diet (LCD): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
|
Control Diet
n=5 Participants
1000 calorie diet
Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Control diet
|
|---|---|---|---|
|
Operative Time
|
86 minutes
Standard Deviation 13
|
72 minutes
Standard Deviation 8
|
72 minutes
Standard Deviation 6
|
Adverse Events
2-week LCD and Roux-en-Y Gastric Bypass (RYGB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6-week LCD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Diet
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