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Sponsored by: |
Hvidovre University Hospital |
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Information provided by: | Hvidovre University Hospital |
ClinicalTrials.gov Identifier: | NCT00810823 |
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 |
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Type 2 Diabetes |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes |
Blood sampels
Estimated Enrollment: | 3 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1:Gastric bypass/diabetes
Patients undergoing gastric bypass surgery, and who are diagnosed with type 2 diabetes.
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2:Gastric bypass/not Diabetic
Patients undergoing gastric bypass surgery, not diagnosed with diabetes.
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3:Gastric banding/diabetes
Patients diagnosed with type 2 diabetes undergoing gastric banding.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Patiens undergoing gastric bypass surgery with or without type 2 diabetes and patients with diabetes undergoing gastric banding
Inclusion Criteria:
Exclusion Criteria:
Contact: Sten Madsbad, professor MDSc | sten.madsbad@hvh.regionh.dk |
Denmark | |
Hvidovre Hospital | |
Hvidovre, Denmark, 2650 |
Responsible Party: | Hvidovre Univesity Hospital, department of endocrinology ( Professor, DMSc Sten Madsbad ) |
Study ID Numbers: | H-A-2008-080 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810823 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
Diabetes gastric bypass type 2 diabetes and gastric bypass |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |