Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05989867
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'steamed bun meal test result 1', 'timeFrame': 'Within 5 hours after the end of the steamed bread meal test', 'description': 'Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)'}, {'measure': 'steamed bun meal test result 2', 'timeFrame': 'Within 6 hours after the end of the steamed bread meal test', 'description': 'Levels of c-peptide bun meal experiment (100g flour made steamed bun)'}, {'measure': 'steamed bun meal test result 3', 'timeFrame': 'Within 7 hours after the end of the steamed bread meal test', 'description': 'Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)'}], 'secondaryOutcomes': [{'measure': 'gut hormone', 'timeFrame': 'up to 1 month', 'description': 'Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)'}, {'measure': 'Continuous glucose monitor results', 'timeFrame': 'after using continuous glucose monitor device for 7-14 days', 'description': 'Time to target range (TIR) : the proportion of time with blood glucose fluctuation'}, {'measure': 'glycemic control', 'timeFrame': 'at the time of enrollment', 'description': 'glycosylated hemoglobin（%）'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis', 'Pancreatogenic Type 3C Diabetes Mellitus', 'Diabetes Mellitus', 'Oral Glucose Tolerance Test']}, 'descriptionModule': {'briefSummary': 'To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.', 'detailedDescription': 'Blood samples will be collected from patients with chronic pancreatitis by oral glucose tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites, and serum biochemical factors to characterize the pathophysiological features of PPDM-C and provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic fluctuations in patients with chronic pancreatitis combined with diabetes and guide subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic pancreatitis who had new-onset diabetes or poor glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 15-85\n2. patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).\n3. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.\n4. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.\n5. patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.\n\nExclusion Criteria:\n\n1. Participants with suspected malignant tumors of the pancreas or other sites of the body (including pancreatic cyst and Benign pancreatic tumor), or participants in the terminal stage of severe disease\n2. Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.\n3. Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate aminotransferase \\> 3 times the upper reference limit) or kidney (eGFR\\<60 mL/min/1.73 m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver diseases such as hepatitis B or hepatic cirrhosis.\n4. Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose\n5. Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs, and antipsychotics)\n6. Acute complications of diabetes (diabetic ketoacidosis, severe hypoglycemia), severe microvascular disease (proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment), and macrovascular disease (uncontrolled arterial hypertension, uncontrolled coronary artery disease, congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation) within the 12 months prior to enrollment.\n7. Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.\n8. Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.\n9. Patients who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT05989867', 'briefTitle': 'Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial', 'orgStudyIdInfo': {'id': 'ESTABLISH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CP', 'description': 'patients with chronic pancreatitis but not combined with diabetes', 'interventionNames': ['Diagnostic Test: blood test']}, {'label': 'PPDM-C', 'description': 'patients with post-chronic pancreatitis diabetes mellitus', 'interventionNames': ['Diagnostic Test: blood test', 'Device: Continuous Glucose Monitor']}, {'label': 'CP+IGT', 'description': 'patients with chronic pancreatitis combined with impaired glucose tolerance', 'interventionNames': ['Diagnostic Test: blood test', 'Device: Continuous Glucose Monitor']}, {'label': 'CP+T2DM', 'description': 'patients with chronic pancreatitis combined with type 2 diabetes mellitus', 'interventionNames': ['Diagnostic Test: blood test', 'Device: Continuous Glucose Monitor']}], 'interventions': [{'name': 'blood test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis.\n\nCharacterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors', 'armGroupLabels': ['CP', 'CP+IGT', 'CP+T2DM', 'PPDM-C']}, {'name': 'Continuous Glucose Monitor', 'type': 'DEVICE', 'description': 'blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )', 'armGroupLabels': ['CP+IGT', 'CP+T2DM', 'PPDM-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhuan liao, MD', 'role': 'CONTACT', 'email': 'liaozhuan@smmu.edu.cn', 'phone': '86-21-31161004'}], 'facility': 'Department of Gastroenterology, Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhuan Liao', 'role': 'CONTACT', 'email': 'liaozhuan@smmu.edu.cn', 'phone': '13061921980'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zhuan Liao', 'investigatorAffiliation': 'Changhai Hospital'}}}}