Meal Stimulating After Roux-en Y Gastric Bypass

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Novo Nordisk A/S
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00915980
First received: June 5, 2009
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests that the remission of the T2DM is due to the direct effect of the operation, more than the secondary effect of the weight loss. The reasons for the major effect on the glucose metabolism after gastric bypass surgery are still unaccounted for.

The aim of this project will be to unveil some of the mechanisms that explain the effect of gastric bypass surgery on the glucose metabolism. Further more to find a better way of testing patients that have just undergone gastric bypass surgery. It is not possible to test patients who have just undergone gastric bypass surgery with normal oral glucose tolerance test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose level and meal-testing with a protein drink.

The hypothesis of the study is that the investigators can see changes in different hormones and adipokines before and after surgery, even with modified OGTT and meal testing. The project will consist of clinical trials on patients without T2DM that will undergo gastric bypass surgery. The studies will take place before and within the first week after surgery. The investigators will measure different hormones and adipokines after OGTT and a meal with a protein drink. The investigators expect to see significant changes in some of the analyses after the operation in patients undergoing gastric bypass.


Condition Intervention
Gastric Bypass
Obesity
Procedure: gastric bypass surgery and testing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Meal Stimulating After Roux-en Y Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Biospecimen Retention:   Samples Without DNA

plasma and serum sampels for analysis of primarily intestinal hormones


Enrollment: 8
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients without diabetes undergoing gastric bypass Procedure: gastric bypass surgery and testing
The patients will be tested with OGTT and meal testing before and after undergoing gastric bypass surgery.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obese with BMI > 40 undergoing gastric bypass surgery or obese with BMI > 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery.

Criteria

Inclusion Criteria:

  • Obese with BMI> 40 undergoing gastric bypass surgery OR
  • Obese with BMI > 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery
  • Age between 20-60 years

Exclusion Criteria:

  • Age > 60
  • Diabetes
  • Psychiatric illness
  • Mentally challenged
  • Addiction
  • Serious cardiac or lung diseases
  • Diseases in the abdomen
  • Other serious illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915980

Locations
Denmark
Hvidovre hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Novo Nordisk A/S
  More Information

No publications provided

Responsible Party: Siv Hesse Jacobsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00915980     History of Changes
Other Study ID Numbers: H-C-2007-0108
Study First Received: June 5, 2009
Last Updated: July 6, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Meal-test
reduced OGTT
gastric bypass surgery and glucose metabolism
Glucose metabolism before and after gastric bypass
Different OGTT
New meal- test

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014