Status:
UNKNOWN
Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization
Lead Sponsor:
Changhai Hospital
Conditions:
Chronic Pancreatitis
Pancreatogenic Type 3C Diabetes Mellitus
Eligibility:
All Genders
15-85 years
Brief Summary
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 w...
Detailed Description
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 pat...
Eligibility Criteria
Inclusion
- Age 15-85
- patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
- participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
- participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.
- patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.
Exclusion
- 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
- Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
- 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.
- Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
- 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)
- 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.
- Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
- Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
- Patients who refused to participate in the study
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05989867
Start Date
March 1 2023
End Date
March 1 2025
Last Update
August 14 2023
Active Locations (1)
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1
Department of Gastroenterology, Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433