MedTrace Logo

The Effect of Gastric Bypass Surgery on Diabetes

NCT01330251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2017-11-01

No results posted yet for this study

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

  • Type II Diabetes

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Vesa Koivukangas, MD, PhD · Oulu University Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330251 on ClinicalTrials.gov