The Effect of Gastric Bypass Surgery on Diabetes

Type II Diabetes Clinical Trial

Official title:

Laihdutusleikkauksen Vaikutus Diabetekseen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330251
• Other study ID #: Laihdutusleikkaustutkimus
• Status: Completed
• Phase: N/A
• First received: March 22, 2011
• Last updated: October 31, 2017
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria (patients with surgery):

• Patients having Roux-en-Y gastric bypass (according to clinical guidelines)

• Age: 18-65 years

Inclusion Criteria (control patients without surgery):

• Patients having gastroscopy (for various clinical reasons)

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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