An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus

• Sponsor: Changhai Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05764629
• Collaborator: (none)
• Enrollment: 324
• Location: 1
• Anticipated Duration (Months): 30.4
• Patients Per Site Per Month: 10.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis; Diabetes Mellitus	Diagnostic Test: blood test; Drug: pharmacologic approaches to glycemic treatment

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 Design

• Study Type: Observational
• Actual Enrollment: 324 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Feb 29, 2024
• Anticipated Study Completion Date: Mar 15, 2024

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c (HbA1c) [through study completion, an average of 1 year]

   measure the control of blood glucose of every 3 months

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Changhai Hospital	Shanghai		China

Sponsors and Collaborators

• Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Liao, Principal Investigator, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT05764629
• Other Study ID Numbers: PPDM-C
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Diabetes Mellitus

Study Results

No Results Posted as of Mar 10, 2023