Chronic PancreatitisNCT05764629
An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
An observational study of Chronic Pancreatitis and Diabetes Mellitus, run by Changhai Hospital at 1 site in China.
Trial summary
To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Diabetes Mellitus
- What is being tested?
- blood test and pharmacologic approaches to glycemic treatment
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consequent patients with a diagnosis of PPDM-C in Changhai Hospital between 2018 to 2022
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment 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).
Read the 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.
- Conditions
- Chronic Pancreatitis, Diabetes Mellitus
- Being tested
- blood test, pharmacologic approaches to glycemic treatment
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
Testing the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc.
pharmacologic approaches to glycemic treatmentDrug
documenting the change of glycemic treatment during the follow-up period
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
measure the control of blood glucose of every 3 months
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Adverse events
Incidence and frequency (number of events) of adverse events (%) such as hypoglycemia, cardiovascular disease, etc.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Sep 2021
- Primary completion29 Feb 2024 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764629
- Sponsor's protocol ID
- PPDM-C
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2023
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05764629
- Acronym / sponsor ID
- PPDM-C
- Conditions
- Chronic Pancreatitis, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consequent patients with a diagnosis of PPDM-C in Changhai Hospital between 2018 to 2022
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testTesting the peripheral blood for PPDM-C, including blood glucose, glycated hemoglobin A1c, fasting insulin and C-peptide, etc. | Diagnostic test | – |
| pharmacologic approaches to glycemic treatmentdocumenting the change of glycemic treatment during the follow-up period | Drug | – |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: through study completion, an average of 1 year
measure the control of blood glucose of every 3 months
1 secondary outcome
Adverse events
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Diabetes Mellitus, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.