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Effect of Gastric Bypass Surgery on Energy Metabolism

NCT00939679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-08-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cambridge Weight Plan Limited

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Julie B Schmidt, MSc · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939679 on ClinicalTrials.gov