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The Effect of Gastric Bypass Surgery on Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330251
First Posted: April 6, 2011
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
University of Oulu
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Enrollment: 41
Study Start Date: January 2011
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330251


Locations
Finland
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
  More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01330251     History of Changes
Other Study ID Numbers: Laihdutusleikkaustutkimus
First Submitted: March 22, 2011
First Posted: April 6, 2011
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases