Status:
COMPLETED
Effect of Gastric Bypass Surgery on Energy Metabolism
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Cambridge Weight Plan Limited
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 leve...
Eligibility Criteria
Inclusion
- Age 18-65
- 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
- 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:
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00939679
Start Date
September 1 2009
End Date
April 1 2013
Last Update
August 2 2013
Active Locations (2)
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1
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, Denmark, 1958
2
Hvidovre Hospital
Copenhagen, Denmark, 2650