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| Name | Class |
|---|---|
| Cambridge Weight Plan Limited | INDUSTRY |
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Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.
The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-week LCD and Roux-en-Y gastric bypass (RYGB) | Active Comparator | 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 |
|
| 6-week LCD | Active Comparator | 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 |
|
| Control diet | Other | 1000 calorie diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid formula low-calorie diet (LCD) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet | Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy | at 2 weeks or 6 weeks depending on group |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass | Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass | at 1-month following Roux-en-Y gastric bypass |
| Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Gary S Frost, RD PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Clinical research facility | London | Greater London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Bottin JH, Balogun B, Thomas EL, Fitzpatrick JA, Moorthy K, Leeds AR, Bell JD, Frost GS. Changes in body composition induced by pre-operative liquid low-calorie diet in morbid obese patients undergoing Roux-en-Y gastric bypass. Obesity reviews (March 2014), 15 (suppl 2): 129-176. (T5:S24.05). doi: 10.1111/obr.12151 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | Control Diet | 1000 calorie diet Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery Control diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Numbers are not the same between the flow chart, the baseline results and some outcomes because depending on the variable measured, there are more or less patients. Forexemple, for some variables there might be missing data or a missing timepoint (baseline, visit 2, 3 or 4), For example, 30 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet | Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy | 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. | Posted | Mean | Standard Error | percentage of change in IHCL | at 2 weeks or 6 weeks depending on group |
|
From baseline until visit 4 at 6 months post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost | Imperial College London | 07872850308 | g.frost@imperial.ac.uk |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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|
| Roux-en-Y gastric bypass (RYGB) | Procedure | Participant went through Roux-en-Y gastric bypass (RYGB) surgery |
|
| Control diet | Other |
|
Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass |
| at 6 months following Roux-en-Y gastric bypass |
| Complexity of Surgery | Complexity 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). | at the time of surgery |
| Operative Time | The 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) | at the time of surgery |
| BG001 | 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. |
| BG002 | Control Diet | 1000 calorie diet Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery Control diet |
| BG003 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Control Diet | 1000 calorie diet Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery Control diet |
|
|
| Secondary | Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass | Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass | Posted | Mean | Standard Error | percentage change in IHCL | at 1-month following Roux-en-Y gastric bypass |
|
|
|
| Secondary | Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass | Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass | Posted | Mean | Standard Error | percentage change in IHCL | at 6 months following Roux-en-Y gastric bypass |
|
|
|
| Secondary | Complexity of Surgery | Complexity 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). | Posted | Mean | Standard Error | scores on a scale | at the time of surgery |
|
|
|
| Secondary | Operative Time | The 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) | Posted | Mean | Standard Deviation | minutes | at the time of surgery |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Control Diet | 1000 calorie diet Roux-en-Y gastric bypass (RYGB): Participant went through Roux-en-Y gastric bypass (RYGB) surgery Control diet | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |