Clinical Trials Directory

Trials / Completed

CompletedNCT00939679

Effect of Gastric Bypass Surgery on Energy Metabolism

ERGEM: Effect of Roux-en-Y Gastric Bypass Surgery on Energy Metabolism.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERoux-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.
DIETARY_SUPPLEMENTlow 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.

Timeline

Start date
2009-09-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2009-07-15
Last updated
2013-08-02

Locations

2 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT00939679. Inclusion in this directory is not an endorsement.