Effect of Gastric Bypass Surgery on Energy Metabolism (ERGEM)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Roux-en-Y gastric bypass surgery; Dietary supplement: low calorie diet (1,000 kcal/day)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 1958
    • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
  • Copenhagen, Denmark, 2650
    • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Dietary supplement: 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 Names: Cambridge Weight Plan, Northants, UK.
Active Comparator: Later gastric bypass surgery (10 weeks); These patients will undergo gastric bypass surgery 10 weeks after starting a low calorie diet.	Procedure: 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.; Dietary supplement: 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 Names: Cambridge Weight Plan, Northants, UK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24 hour energy expenditure	7 weeks, 10 weeks (short term); 1.5 years (long term)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Cambridge Weight Plan Limited
• Investigators: Principal Investigator: Julie B Schmidt, MSc, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (Estimate): July 15, 2009

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: GLP-1; obesity; bariatric surgery; body composition; incretins; energy expenditure; appetite regulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: B263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No