An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

Active, not recruiting

• Conditions: Chronic Pancreatitis; Diabetes Mellitus

• Registration Number: NCT05764629
• Lead Sponsor: Changhai Hospital

Brief Summary

To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).

Detailed Description

The present study was an observational study aimed to explore risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus. The observation items included clinical characteristics, blood glucose control and incidence of complications of PPDM-C.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-02-18
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26
• Primary Completion: 2024-02-29
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. patients with diagnosis of chronic pancreatitis and diabetes mellitus.
2. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
3. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.

Exclusion Criteria

1. participants with suspected malignant tumors of the pancreas or other sites of body, or participants in the terminal stage of severe disease
2. serious mental illness, lesion of liver or kidney, pregnancy, breast-feeding or planning pregnancy
3. definitely diagnosed type 1 diabetes, type 2 diabetes, or other metabolic diseases that affect blood glucose
4. autoimmune pancreatitis
5. Scarcity of information related to HbA1c
6. death or loss of follow-up during follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	through study completion, an average of 1 year	measure the control of blood glucose of every 3 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	through study completion, an average of 1 year	Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc.

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China