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The Effect of Gastric Bypass Surgery on Diabetes

NCT ID: NCT01330251

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Type II Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetes having Roux-en-Y gastric bypass

No interventions assigned to this group

Patients without diabetes having Roux-en-Y gastric bypass

No interventions assigned to this group

Control subjects (patients having gastroscopy, no surgery)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients having Roux-en-Y gastric bypass (according to clinical guidelines)
* Age: 18-65 years


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vesa Koivukangas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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Zhao S, Horkko S, Savolainen MJ, Koivukangas V, Makinen VP, Ala-Korpela M, Hukkanen J. Short-Term Metabolic Changes and Their Physiological Mediators in the Roux-en-Y Gastric Bypass Bariatric Surgery. Obes Surg. 2024 Feb;34(2):625-634. doi: 10.1007/s11695-023-07042-y. Epub 2024 Jan 9.

Reference Type DERIVED
PMID: 38191968 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35229613 (View on PubMed)

Other Identifiers

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Laihdutusleikkaustutkimus

Identifier Type: -

Identifier Source: org_study_id