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| Name | Class |
|---|---|
| Cambridge Weight Plan Limited | INDUSTRY |
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The purpose of this study is to investigate the short term and long term effects of Roux-en-Y gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating hormone levels, and appetite sensation. We hypothesize that following RYGB surgery, metabolism will be elevated in comparison to patients who have not yet had RYGB but who are losing weight simultaneously using a low calorie diet. We further hypothesize that this higher metabolism will be associated with alterations in fasting and postmeal levels of gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we hypothesize that differences in metabolism, body composition, and hormone levels will distinguish between patients who have maintained their weight loss after RYGB vs those who have regained weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Earlier gastric bypass surgery (7 weeks) | Experimental | These patients will undergo gastric bypass surgery 7 weeks after starting a low calorie diet, and will continue the low calorie diet for 3 weeks following surgery. |
|
| Later gastric bypass surgery (10 weeks) | Active Comparator | These patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y gastric bypass surgery | Procedure | Briefly, RYGB is characterized first by creation of a small stomach pouch. The small intestine is then divided approximately 75 cm distal to the ligament of Treitz, creating a proximal intestinal limb that transports the secretions from the stomach remnant, liver, and pancreas, and a 'Roux' limb, that is attached to the new stomach pouch to drain consumed food. The distal end of the proximal limb is then reattached approximately 100 cm distal to the new stomach drainage site, creating a common channel where digestive enzymes mix with ingested food. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 hour energy expenditure | 7 weeks, 10 weeks (short term); 1.5 years (long term) |
| Measure | Description | Time Frame |
|---|---|---|
| change in fasting bile acids and lipid profile | 7 weeks, 10 weeks (short term); 1.5 years (long term) | |
| changes in fasting levels of leptin, adiponectin, and visfatin | 7 weeks, 10 weeks (short term); 1.5 years (long term) |
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Inclusion Criteria:
Exclusion Criteria:
Deemed ineligible for RYGB surgery by patient's own physician(s)
Diabetes Mellitus
Non Caucasian
Weight >160kg (due to DEXA scanner limitations), or morphologically unable to accommodate in DEXA scanner (>40cm in maximum supine anterior-posterior dimension, or >60cm in maximum supine body width)
Hemoglobin <7.0 mmol/L
Psychiatric illness under the care of a psychiatrist
Eating disorder such as bulimia
Patients on special diets (eg vegetarian, Atkins)
Any history of thyroid dysfunction, or use of thyroid medication (with the exception of transient thyroiditis)
Hypothalamic or genetic etiology of obesity
A current diagnosis of cancer
Any surgery other than RYGB planned in the ensuing 3 months
Substance abuse or smoking
Use of prescription medications or over-the-counter drugs affecting metabolism
Excessive intake of alcohol (>7 drinks/week)
Excessive intake of caffeine (>300 mg/day)
Presence of any contraindication to use of a low calorie powder diet, including:
Do not enjoy yogurt, carrots, or milk (as these are essential elements of the low calorie diet)
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| Name | Affiliation | Role |
|---|---|---|
| Julie B Schmidt, MSc | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen | Copenhagen | 1958 | Denmark | |||
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| low calorie diet (1,000 kcal/day) | Dietary Supplement | Patients will consume a daily diet composed of:
The diet will be consumed by both groups for a 10 week period. |
|
|
| change in body composition | 7 weeks, 10 weeks (short term); 1.5 years (long term) |
| Change in appetite sensation | 7 weeks, 10 weeks (short term); 1.5 years (long term) |
| change in fasting and postprandial levels of GLP-1, PYY, oxyntomodulin, glucose, insulin, C peptide, GIP, ghrelin, cholecystokinin | 7 weeks, 10 weeks (short term); 1.5 years (long term) |
| Hvidovre Hospital |
| Copenhagen |
| 2650 |
| Denmark |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |