CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01330251
NCT01330251N/ACompleted

Laihdutusleikkauksen Vaikutus Diabetekseen

University of Oulu·observational·Posted Apr 6, 2011·Updated Nov 1, 2017

In Brief

An observational study for Type II Diabetes. Completed, enrolled 41 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFinland

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2011
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 15.2 years ago