The Effect of Gastric Bypass Surgery on Diabetes

This study is currently recruiting participants.

Verified September 2012 by University of Oulu

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2011

Last Updated Date

September 7, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01330251 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Gastric Bypass Surgery on Diabetes

Official Title ^ICMJE

Laihdutusleikkauksen Vaikutus Diabetekseen

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Serum, plasma, feces, intestinal tissue

Sampling Method

Non-Probability Sample

Study Population

All patients are recruited from Oulu University Hospital

Condition ^ICMJE

Type II Diabetes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Vesa Koivukangas, MD, PhD

+35883152832

vesa.koivukangas@ppshp.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01330251

Other Study ID Numbers ^ICMJE

Laihdutusleikkaustutkimus

Has Data Monitoring Committee

Responsible Party

University of Oulu

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Oulu University Hospital

Investigators ^ICMJE

Principal Investigator:

Vesa Koivukangas, MD, PhD

Oulu University Hospital

Information Provided By

University of Oulu

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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