ObesityERGEMNCT00939679
Effect of Gastric Bypass Surgery on Energy Metabolism
A study testing Roux-en-Y gastric bypass surgery and low calorie diet (1,000 kcal/day) in people with Obesity, run by University of Copenhagen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Roux-en-Y gastric bypass surgery and low calorie diet (1,000 kcal/day)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Copenhagen, 1958
Hvidovre Hospital
Copenhagen, 2650
About this study
Official title: ERGEM: Effect of Roux-en-Y Gastric Bypass Surgery on Energy Metabolism.
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.
- Conditions
- Obesity
- Being tested
- Roux-en-Y gastric bypass surgery, low calorie diet (1,000 kcal/day)
- Keywords
- obesity, bariatric surgery, energy expenditure, incretins, appetite regulation, body composition, GLP-1
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypass surgeryProcedure or 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)Dietary supplement
Also called Cambridge Weight Plan, Northants, UK.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Roux-en-Y gastric bypass surgery; Dietary Supplement: low calorie diet (1,000 kcal/day) |
| Later gastric bypass surgery (10 weeks) | Active comparator | These patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet. Receives: Procedure: Roux-en-Y gastric bypass surgery; Dietary Supplement: low calorie diet (1,000 kcal/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 hour energy expenditure
Measured: 7 weeks, 10 weeks (short term); 1.5 years (long term)
Secondary outcomes (5)
change in fasting bile acids and lipid profile
Measured: 7 weeks, 10 weeks (short term); 1.5 years (long term)
changes in fasting levels of leptin, adiponectin, and visfatin
Measured: 7 weeks, 10 weeks (short term); 1.5 years (long term)
change in body composition
Measured: 7 weeks, 10 weeks (short term); 1.5 years (long term)
Change in appetite sensation
Measured: 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
Measured: 7 weeks, 10 weeks (short term); 1.5 years (long term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Weight Plan Limited
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Julie B Schmidt, MSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939679
- Sponsor's protocol ID
- B263
- Acronym
- ERGEM
- Status last verified
- Aug 2013
- First submitted
- 14 Jul 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERGEM: Effect of Roux-en-Y Gastric Bypass Surgery on Energy Metabolism.
- ClinicalTrials.gov ID
- NCT00939679
- Acronym / sponsor ID
- ERGEM / B263
- Conditions
- Obesity
- Keywords
- obesity, bariatric surgery, energy expenditure, incretins, appetite regulation, body composition, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Cambridge Weight Plan Limited
- Study start
- Sep 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Earlier gastric bypass surgery (7 weeks) | Experimental | Procedure: Roux-en-Y gastric bypass surgery, Dietary Supplement: low calorie diet (1,000 kcal/day)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 | Procedure: Roux-en-Y gastric bypass surgery, Dietary Supplement: low calorie diet (1,000 kcal/day)These patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y gastric bypass surgeryBriefly, 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. | Procedure or surgery | Earlier gastric bypass surgery (7 weeks), Later gastric bypass surgery (10 weeks) |
| low calorie diet (1,000 kcal/day)Also: Cambridge Weight Plan, Northants, UK.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. | Dietary supplement | Earlier gastric bypass surgery (7 weeks), Later gastric bypass surgery (10 weeks) |
Primary outcome
Change in 24 hour energy expenditure
Time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)
5 secondary outcomes
change in fasting bile acids and lipid profile
Time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)
changes in fasting levels of leptin, adiponectin, and visfatin
Time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)
change in body composition
Time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)
Change in appetite sensation
Time frame: 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
Time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie B Schmidt, MSc principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y gastric bypass surgery and low calorie diet (1,000 kcal/day) in people with Obesity, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24 hour energy expenditure (time frame: 7 weeks, 10 weeks (short term); 1.5 years (long term)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.