The Effect of Gastric Bypass Surgery on Diabetes

Completed

• Conditions: Type II Diabetes

• Registration Number: NCT01330251
• Lead Sponsor: University of Oulu

Brief Summary

This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery

Hypotheses are:

* The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells

* The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes

* The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis

* The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation

* The gastric bypass surgery changes cholesterol and bile acid metabolism

* The gastric bypass surgery changes the fecal microbiota

Primary end points are:

* Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum

* Changes in the incretine secretion studied with liquid meal test

* Changes in the oxidation of lipoproteins

* Changes in the immunologic markers in ventricle, duodenum and jejunum

* Changes in the amounts of phytosterols, cholesterol metabolites and bile acids

* Changes in fecal microbiota

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

• Diabetes (applies for control patients)
• BMI over 30 (applies for control patients)
• Insulin treatment
• Oral corticosteroid treatment
• Chronic inflammatory disease
• Coeliac disease
• Malignant disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the oxidation of lipoproteins	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the incretine secretion studied with liquid meal test	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in fecal microbiota	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the immunologic markers in ventricle, duodenum and jejunum	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the amounts of phytosterols, cholesterol metabolites and bile acids	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum	baseline to 6 months	Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland