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NCT05764629 Clinical Trial

An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05764629
Other study ID # PPDM-C
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2030

Study information
Verified date March 2023
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 324
Est. completion date December 31, 2030
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• blood test
Testing the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc.
Drug:
• pharmacologic approaches to glycemic treatment
documenting the change of glycemic treatment during the follow-up period

Locations
Country Name City State
China Shanghai Changhai Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c (HbA1c) measure the control of blood glucose of every 3 months through study completion, an average of 1 year
Secondary Adverse events Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc. through study completion, an average of 1 year
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