Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2009-09-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Earlier gastric bypass surgery (7 weeks)
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.
Roux-en-Y gastric bypass surgery
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.
low calorie diet (1,000 kcal/day)
Patients will consume a daily diet composed of:
* 4 powder diet portions (Cambridge Diets, UK)
* plain yogurt (100-125g)
* skim milk (1L)
* a limited variety of vegetables
The diet will be consumed by both groups for a 10 week period.
Later gastric bypass surgery (10 weeks)
These patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet.
Roux-en-Y gastric bypass surgery
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.
low calorie diet (1,000 kcal/day)
Patients will consume a daily diet composed of:
* 4 powder diet portions (Cambridge Diets, UK)
* plain yogurt (100-125g)
* skim milk (1L)
* a limited variety of vegetables
The diet will be consumed by both groups for a 10 week period.
Interventions
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Roux-en-Y gastric bypass surgery
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.
low calorie diet (1,000 kcal/day)
Patients will consume a daily diet composed of:
* 4 powder diet portions (Cambridge Diets, UK)
* plain yogurt (100-125g)
* skim milk (1L)
* a limited variety of vegetables
The diet will be consumed by both groups for a 10 week period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≥40, or ≥35 with concomitant obstructive sleep apnea, or hypertension
* scheduled for RYGB surgery at Hvidovre Hospital, Copenhagen, Denmark
* Must have lost between 1-4% body weight after 3 months of dietary counselling
Exclusion Criteria
* 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:
* Past history of ventricular arrhythmias (even if treated)
* Renal dysfunction (creatinine clearance \<60 mL/min)
* Liver enzymes (ALT or AST) \>3x upper limit of normal
* Milk protein allergy, or lactose intolerance
* Porphyria or phenylketonuria
* History of gout
* Breastfeeding
* Concomitant use of monoamine oxidase inhibitors or non potassium sparing diuretics
* Inability or unwillingness to comply with a low calorie diet protocol
* Patients who find the powder diet products to be unpalatable
* Do not enjoy yogurt, carrots, or milk (as these are essential elements of the low calorie diet)
18 Years
65 Years
ALL
No
Sponsors
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Cambridge Weight Plan Limited
INDUSTRY
University of Copenhagen
OTHER
Responsible Party
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AAstrup
Head of Department
Principal Investigators
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Julie B Schmidt, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, , Denmark
Hvidovre Hospital
Copenhagen, , Denmark
Countries
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Other Identifiers
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B263
Identifier Type: -
Identifier Source: org_study_id