The Effect of Gastric Bypass Surgery on Diabetes
This study is currently recruiting participants.
Verified September 2012 by University of Oulu
Sponsor:
University of Oulu
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01330251
First received: March 22, 2011
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
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
| Condition |
|---|
|
Type II Diabetes |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Laihdutusleikkauksen Vaikutus Diabetekseen |
Resource links provided by NLM:
Further study details as provided by University of Oulu:
Primary Outcome Measures:
- Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
- Changes in the incretine secretion studied with liquid meal test [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
- Changes in the oxidation of lipoproteins [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
- Changes in the immunologic markers in ventricle, duodenum and jejunum [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
- Changes in the amounts of phytosterols, cholesterol metabolites and bile acids [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
- Changes in fecal microbiota [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
Biospecimen Retention: Samples With DNA
Serum, plasma, feces, intestinal tissue
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients with diabetes having Roux-en-Y gastric bypass |
| Patients without diabetes having Roux-en-Y gastric bypass |
| Control subjects (patients having gastroscopy, no surgery) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients are recruited from Oulu University Hospital
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330251
Contacts
| Contact: Vesa Koivukangas, MD, PhD | +35883152832 | vesa.koivukangas@ppshp.fi |
Locations
| Finland | |
| Oulu University Hospital | Recruiting |
| Oulu, Finland, 90220 | |
| Principal Investigator: Vesa Koivukangas, MD, PhD | |
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
| Principal Investigator: | Vesa Koivukangas, MD, PhD | Oulu University Hospital |
More Information
No publications provided
| Responsible Party: | University of Oulu |
| ClinicalTrials.gov Identifier: | NCT01330251 History of Changes |
| Other Study ID Numbers: | Laihdutusleikkaustutkimus |
| Study First Received: | March 22, 2011 |
| Last Updated: | September 7, 2012 |
| Health Authority: | Finland: Ethics Committee |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013