Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 5:44 AM
Study NCT ID:
NCT01388192
Status:
UNKNOWN
Last Update Posted:
2016-01-26
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pancreaticoduodenectomy on Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of glucose metabolism after pancreaticoduodenectomy', 'timeFrame': 'on the post-operative day 5 and day 6', 'description': 'Measurement of glucose, glucagon-like peptide-1, Measurement of insulin, C-peptide, and glucagon concentrations after meal test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreaticoduodenectomy', 'diabetes', 'sugar metabolism'], 'conditions': ['Diabetes Mellitus', 'Glucose Intolerance']}, 'descriptionModule': {'briefSummary': 'Pancreaticoduodenectomy (PD) involves removing the head of pancreas, duodenum, common bile duct, gall bladder, and/or distal stomach. In general, the postoperative changes are thought to be moderately severe, and about 20% of these patients go on to develop new clinical diabetes. PD-related factors of glucose metabolism will include removal of half of the pancreatic endocrine tissue, exclusion of the proximal small intestine, postoperative weight loss (on average, \\~8% of body weight), and removal of putative diabetogenic factor in resected neoplasm. However, effect of removal of duodenum on glucose metabolism after PD has never been studied. The investigators plan to examine this issue by comparing fasting plasma levels of insulin, fasting plasma glucose, C-peptide, HbA1C, HOMA-insulin resistance, GLP-1 response after a standard meal, and body mass index (BMI) of patients before and after PD.', 'detailedDescription': 'Questionaire All studied patients will be requested to self-complete a detailed questionnaire that collects information on demographic data, including usual adult height and weight, and history of DM in first-degree relatives. Existing medical conditions, including DM, duration of these medical problems, and current medications will also be inquired. The database will also include details of weight measured at the time of recruitment and body mass index (BMI), calculated as weight (kg)/height2 (m2). All studied patients will have FBG levels measured. Patients receiving prescription antidiabetic medications for previously diagnosed DM will be classified as having DM regardless of their FBG value. Among patients not reporting treatment for DM, classification of DM status will be based on the American Diabetes Association criteria; patients will be classified as having DM if the FBG level is ≧126 mg/dL (7 mmol/L), as having impaired fasting glucose (IFG) if their FBG is between 100 and 125 mg/dL (5.6-6.9 mmol/L), and as having normal fasting glucose (NFG) if their FBG value is ≦99 mg/dL (5.5 mmol/L).\n\nAfter withdrawal of anti-diabetic medications for 12 h, the patients were asked to fast overnight for 12 h, then were given 200 ml of formula (220kcal, 14g of protein, 28 g of carbohydrates, and 5 g of fat; Modifast, Stocksund, Sweden) within 10 min through a NG tube on post-operative day 5 (proximal feeding group \\[PFG\\]) and a jejunostomy feeding tube (distal feeding group \\[DFG\\]) on post-operative day 6. The below parameter will be checked, including\n\n1. HOMA insulin resistance assessment (HOMA-IR)\n2. GLP-1\n3. GIP\n4. C-peptide\n5. Insulin\n6. Glucose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving pancreaticoduodenectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving pancreaticoduodenectomy\n\nExclusion Criteria:\n\n* history of pancreatitis\n* hepatic dysfunction (Child-Pugh \\> 2)\n* renal dysfunction (serum creatinine concentration \\> 3 mg/L, hemodialysis, or both)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01388192', 'briefTitle': 'Effects of Pancreaticoduodenectomy on Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Pancreaticoduodenectomy on Glucose Metabolism', 'orgStudyIdInfo': {'id': '201104028RC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Receiving pancreaticoduodenectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Wen Tien, Ph.D.', 'role': 'CONTACT', 'email': 'kptkptkpt@yahoo.com.tw', 'phone': '+886-972651427'}, {'name': 'Yu-Wen Tien, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Yu-Wen Tien, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'Ywtien5106@ntu.edu.tw', 'phone': '+886-0972651427'}], 'overallOfficials': [{'name': 'Yu-Wen Tien, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}