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The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810823
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : July 6, 2011
Information provided by:
Hvidovre University Hospital

Brief Summary:

Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early as 1 - 2 days after surgery and this is before any real weight loss has occurred. This suggest that the remission of the diabetes is due to the direct effect of the operation more that the secondary effect of the weight loss. The reason for the major effect on the glucose metabolism after gastric bypass surgery is still unaccounted for.

This PhD. project will try to unveil some of the mechanisms that could explain the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes.

The hypothesis of the study is that a factor "X" will course the remission of the diabetes. This factor "X" is related to the anatomic changes of the gastro intestinal tract, by eliminating the foods passage through the distal part of the ventricle and the duodenum, in combination with the Roux- en-Y sling.

The PhD. project will consist of clinical trails on patients that will undergo gastric bypass surgery. The studies will take place before and within the 1. week after surgery. The investigators will measure different hormones and adipokines in fast and the postprandial state. To discover possible new proteins the investigators will run proteomic on some samples. All the results will be compared to the same parameter on patients undergoing gastric banding, where the anatomy of the intestine hasn't been changed.

Condition or disease
Type 2 Diabetes

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes
Study Start Date : January 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

1:Gastric bypass/diabetes
Patients undergoing gastric bypass surgery, and who are diagnosed with type 2 diabetes.
2:Gastric bypass/not Diabetic
Patients undergoing gastric bypass surgery, not diagnosed with diabetes.

Primary Outcome Measures :
  1. What is the factor "X" that cause the remission of type 2 diabetes after gastric bypass [ Time Frame: about 3 years ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patiens undergoing gastric bypass surgery with or without type 2 diabetes and patients with diabetes undergoing gastric banding

Inclusion Criteria:

  • The inclusion criteria in Denmark for undergoing gastric bypass and see the above study and cohort description.
  • Well treated hypertension < 145/85. HbA1C <8,5 % and c-peptid> 700pmol/l

Exclusion Criteria:

  • In treatment with antidepressive, DPP-4 inhibitors and intreatment for thyroid problems.
  • Patients treated with insulin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810823

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Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor, DMSc Sten Madsbad, Hvidovre Univesity Hospital, department of endocrinology Identifier: NCT00810823    
Other Study ID Numbers: H-A-2008-080
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: December 2008
Keywords provided by Hvidovre University Hospital:
gastric bypass
type 2 diabetes and gastric bypass
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases