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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00810823
First received: December 17, 2008
Last updated: July 5, 2011
Last verified: December 2008
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • What is the factor "X" that cause the remission of type 2 diabetes after gastric bypass [ Time Frame: about 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Enrollment: 25
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00810823

Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor, DMSc Sten Madsbad, Hvidovre Univesity Hospital, department of endocrinology
ClinicalTrials.gov Identifier: NCT00810823     History of Changes
Other Study ID Numbers: H-A-2008-080
Study First Received: December 17, 2008
Last Updated: July 5, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Hvidovre University Hospital:
Diabetes
gastric bypass
type 2 diabetes and gastric bypass

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014