An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pancreatitis Chronic Disease Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Changhai Hospital

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with diagnosis of chronic pancreatitis and diabetes mellitus.
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.

Exclusion criteria

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

Treatment and study plan

Blood test

Diagnostic Test

Testing the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc.

pharmacologic approaches to glycemic treatment

Drug

documenting the change of glycemic treatment during the follow-up period

Primary outcomes

Hemoglobin A1c (HbA1c)

Time frame: through study completion, an average of 1 year

measure the control of blood glucose of every 3 months

Secondary outcomes

Adverse events

Time frame: through study completion, an average of 1 year

Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2030
First posted: Mar 10, 2023
Registry last updated: May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed