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

Recruiting

• Conditions: Diabetes Mellitus; Oral Glucose Tolerance Test; Pancreatogenic Type 3C Diabetes Mellitus; Chronic Pancreatitis
• Interventions: Diagnostic Test: blood test; Device: Continuous Glucose Monitor

• Registration Number: NCT05989867
• Lead Sponsor: Changhai Hospital

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 which provide evidence for the diagnosis of PPDM-C.

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 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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CP	blood test	patients with chronic pancreatitis but not combined with diabetes
PPDM-C	blood test	patients with post-chronic pancreatitis diabetes mellitus
PPDM-C	Continuous Glucose Monitor	patients with post-chronic pancreatitis diabetes mellitus
CP+IGT	blood test	patients with chronic pancreatitis combined with impaired glucose tolerance
CP+IGT	Continuous Glucose Monitor	patients with chronic pancreatitis combined with impaired glucose tolerance
CP+T2DM	Continuous Glucose Monitor	patients with chronic pancreatitis combined with type 2 diabetes mellitus
CP+T2DM	blood test	patients with chronic pancreatitis combined with type 2 diabetes mellitus

Primary Outcome Measures

Name	Time	Method
steamed bun meal test result 3	Within 7 hours after the end of the steamed bread meal test	Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 2	Within 6 hours after the end of the steamed bread meal test	Levels of c-peptide bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 1	Within 5 hours after the end of the steamed bread meal test	Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)

Secondary Outcome Measures

Name	Time	Method
gut hormone	up to 1 month	Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)
Continuous glucose monitor results	after using continuous glucose monitor device for 7-14 days	Time to target range (TIR) : the proportion of time with blood glucose fluctuation
glycemic control	at the time of enrollment	glycosylated hemoglobin（%）

Trial Locations

Locations (1)

Department of Gastroenterology, Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China