Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01330251
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2011-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Gastric Bypass Surgery on Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, feces, intestinal tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2011-03-22', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}, {'measure': 'Changes in the incretine secretion studied with liquid meal test', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}, {'measure': 'Changes in the oxidation of lipoproteins', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}, {'measure': 'Changes in the immunologic markers in ventricle, duodenum and jejunum', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}, {'measure': 'Changes in the amounts of phytosterols, cholesterol metabolites and bile acids', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}, {'measure': 'Changes in fecal microbiota', 'timeFrame': 'baseline to 6 months', 'description': 'Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type II Diabetes']}, 'referencesModule': {'references': [{'pmid': '38191968', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35229613', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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\n\nHypotheses are:\n\n* The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells\n* The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes\n* The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis\n* The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation\n* The gastric bypass surgery changes cholesterol and bile acid metabolism\n* The gastric bypass surgery changes the fecal microbiota\n\nPrimary end points are:\n\n* Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum\n* Changes in the incretine secretion studied with liquid meal test\n* Changes in the oxidation of lipoproteins\n* Changes in the immunologic markers in ventricle, duodenum and jejunum\n* Changes in the amounts of phytosterols, cholesterol metabolites and bile acids\n* Changes in fecal microbiota'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients are recruited from Oulu University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (patients with surgery):\n\n* Patients having Roux-en-Y gastric bypass (according to clinical guidelines)\n* Age: 18-65 years\n\nInclusion Criteria (control patients without surgery):\n\n* Patients having gastroscopy (for various clinical reasons)\n\nExclusion Criteria:\n\n* Diabetes (applies for control patients)\n* BMI over 30 (applies for control patients)\n* Insulin treatment\n* Oral corticosteroid treatment\n* Chronic inflammatory disease\n* Coeliac disease\n* Malignant disease'}, 'identificationModule': {'nctId': 'NCT01330251', 'briefTitle': 'The Effect of Gastric Bypass Surgery on Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Laihdutusleikkauksen Vaikutus Diabetekseen', 'orgStudyIdInfo': {'id': 'Laihdutusleikkaustutkimus'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diabetes having Roux-en-Y gastric bypass'}, {'label': 'Patients without diabetes having Roux-en-Y gastric bypass'}, {'label': 'Control subjects (patients having gastroscopy, no surgery)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Vesa Koivukangas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oulu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}