The Effect of Gastric Bypass Surgery on Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Oulu.
Recruitment status was  Recruiting
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014