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Trials / Completed

CompletedNCT01330251

The Effect of Gastric Bypass Surgery on Diabetes

Laihdutusleikkauksen Vaikutus Diabetekseen

Status
Completed
Phase
Study type
Observational
Enrollment
41 (actual)
Sponsor
University of Oulu · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2011-01-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2011-04-06
Last updated
2017-11-01

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT01330251. Inclusion in this directory is not an endorsement.