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The Effect of Gastric Bypass Surgery on Diabetes

Sponsor
University of Oulu (Other)
Overall Status
Completed
CT.gov ID
NCT01330251
Collaborator
Oulu University Hospital (Other)
41
Enrollment
1
Location
71
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    41 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Laihdutusleikkauksen Vaikutus Diabetekseen
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    2. Changes in the incretine secretion studied with liquid meal test [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    3. Changes in the oxidation of lipoproteins [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    4. Changes in the immunologic markers in ventricle, duodenum and jejunum [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    5. Changes in the amounts of phytosterols, cholesterol metabolites and bile acids [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    6. Changes in fecal microbiota [baseline to 6 months]

      Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Oulu University Hospital Oulu Finland 90220

    Sponsors and Collaborators

    • University of Oulu
    • Oulu University Hospital

    Investigators

    • Principal Investigator: Vesa Koivukangas, MD, PhD, Oulu University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oulu
    ClinicalTrials.gov Identifier:
    NCT01330251
    Other Study ID Numbers:
    • Laihdutusleikkaustutkimus
    First Posted:
    Apr 6, 2011
    Last Update Posted:
    Nov 1, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Nov 1, 2017