Effect of Gastric Bypass Surgery on Energy Metabolism (NCT00939679) | Clinical Trial Compass
CompletedNot Applicable
Effect of Gastric Bypass Surgery on Energy Metabolism
Denmark32 participantsStarted 2009-09
Plain-language 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 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 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:
* 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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.