Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization

Naval Military Medical University

Status: Enrolling

Conditions: Chronic Pancreatitis; Oral Glucose Tolerance Test; Pancreatogenic Type 3C Diabetes Mellitus; Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitor; Diagnostic Test: blood test

Study type: Observational

Funder types: Other

Identifiers

NCT05989867

ESTABLISH

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 15-85
2. patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
3. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
4. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.
5. patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.

Exclusion criteria

1. 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
2. Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
3. 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.
4. Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
5. 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)
6. 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.
7. Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
8. Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
9. Patients who refused to participate in the study

Trial design

200 participants in 4 patient groups

CP

Description:

patients with chronic pancreatitis but not combined with diabetes

Treatment:

Diagnostic Test: blood test

PPDM-C

Description:

patients with post-chronic pancreatitis diabetes mellitus

Treatment:

Device: Continuous Glucose Monitor

Diagnostic Test: blood test

CP+IGT

Description:

patients with chronic pancreatitis combined with impaired glucose tolerance

Treatment:

Device: Continuous Glucose Monitor

Diagnostic Test: blood test

CP+T2DM

Description:

patients with chronic pancreatitis combined with type 2 diabetes mellitus

Treatment:

Device: Continuous Glucose Monitor

Diagnostic Test: blood test