Effect of Gastric Bypass Surgery on Energy Metabolism
ERGEM
ERGEM: Effect of Roux-en-Y Gastric Bypass Surgery on Energy Metabolism.
1 other identifier
interventional
32
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2009
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 2, 2013
August 1, 2013
3.6 years
July 14, 2009
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in 24 hour energy expenditure
7 weeks, 10 weeks (short term); 1.5 years (long term)
Secondary Outcomes (5)
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)
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)
Study Arms (2)
Earlier gastric bypass surgery (7 weeks)
EXPERIMENTALThese 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 COMPARATORThese patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Cambridge Weight Plan Limitedcollaborator
Study Sites (2)
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, 1958, Denmark
Hvidovre Hospital
Copenhagen, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie B Schmidt, MSc
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
September 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 2, 2013
Record last verified: 2013-08