Skip to main content
OpenTrials
Completed

NCT Number: NCT01330251

The Effect of Gastric Bypass Surgery on Diabetes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

Laihdutusleikkauksen Vaikutus Diabetekseen

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2011
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.