Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01330251
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2011-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Gastric Bypass Surgery on Diabetes
Sponsor:
University of Oulu
Organization:
Study Overview
Official Title:
Laihdutusleikkauksen Vaikutus Diabetekseen
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: