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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00810823

Collaborator

(none)

Enrollment

Location

26.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Type 2 Diabetes

Study Design

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 :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

What is the factor "X" that cause the remission of type 2 diabetes after gastric bypass [about 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre Hospital	Hvidovre		Denmark	2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00810823

Other Study ID Numbers:

H-A-2008-080

First Posted:

Dec 18, 2008

Last Update Posted:

Jul 6, 2011

Last Verified:

Dec 1, 2008

Keywords provided by , ,

Diabetes

gastric bypass

type 2 diabetes and gastric bypass

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 6, 2011