Clinical trial NCT01330251: The Effect of Gastric Bypass Surgery on Diabetes
Official title: Laihdutusleikkauksen Vaikutus Diabetekseen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2011-04-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are recruited from Oulu University Hospital

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


Eligibility 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

Primary outcomes:
measure: Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
timeFrame: baseline to 6 months
measure: Changes in the incretine secretion studied with liquid meal test
timeFrame: baseline to 6 months
measure: Changes in the oxidation of lipoproteins
timeFrame: baseline to 6 months
measure: Changes in the immunologic markers in ventricle, duodenum and jejunum
timeFrame: baseline to 6 months
measure: Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
timeFrame: baseline to 6 months
measure: Changes in fecal microbiota
timeFrame: baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Vesa Koivukangas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.