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

July 5, 2011 updated by: Hvidovre University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patiens undergoing gastric bypass surgery with or without type 2 diabetes and patients with diabetes undergoing gastric banding

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
What is the factor "X" that cause the remission of type 2 diabetes after gastric bypass
Time Frame: about 3 years
about 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 5, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-A-2008-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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