Chronic PancreatitisNCT06826729
The Characteristics of Blood Glucose Profile and the Changes of Hormones in PPDM-C Population
An observational study of Chronic Pancreatitis and Diabetes, run by Shanghai Changzheng Hospital.
Trial summary
The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Diabetes
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2025to 1 Jul 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with chronic pancreatitis
Who may be able to join
- Male or female Chinese subjects;
- Was ≥ 18 years old when signing the informed consent;
- Patients with complete diagnosis of chronic pancreatitis; ④ Those who voluntarily signed informed consent; ⑤ Those who complete serum samples in multiple centers and put them into storage.
Who cannot join
- Patients with impaired glucose tolerance but undiagnosed diabetes;
- Patients with T1DM related autoimmune markers or other types of DM;
- Patients with autoimmune pancreatitis, recurrent acute pancreatitis or acute onset of chronic pancreatitis;
- Patients who underwent pancreatic surgery or related invasive procedures during treatment;
- Previous or current malignant tumor; ⑥ Pregnancy or lactation; ⑦ Suffering from severe heart, liver or kidney dysfunction or malignant disease; ⑧ Failure to sign informed consent for cognitive impairment or other reasons.
About this study
Official title: The Characteristics of Blood Glucose Profile and the Changes of Endogenous and Exogenous Hormones in Patients with Post-chronic Pancreatitis Diabetes Mellitus
The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C.
Read the detailed description
The benefits of this study to participants include:
- It will help to make early diagnosis or risk screening for the potential related risks and concomitant diseases of the disease;
- Provide necessary suggestions for the treatment and intervention of the disease, or provide useful information for the related research of the disease.
- We will provide Abbott version h dynamic glucose meter and assessment of internal and external secretion function. The researcher will provide professional endocrine related lifestyle and drug guidance for the subjects according to their CGMS data.
The risks that this study may bring to participants are:
There may be some very small risks in specimen collection, including transient pain, local cyanosis, etc. a few people will have mild dizziness or extremely rare needle infection.
- Conditions
- Chronic Pancreatitis, Diabetes
- Keywords
- chronic pancreatitis, PPDM-C, CGM
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profile characteristics of patients with PPDM-C
Measured: From February 2025 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start11 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (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 Shanghai Changzheng 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826729
- Sponsor's protocol ID
- 2024SL140
- Status last verified
- Nov 2024
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Blood Glucose Profile and the Changes of Endogenous and Exogenous Hormones in Patients with Post-chronic Pancreatitis Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06826729
- Acronym / sponsor ID
- 2024SL140
- Conditions
- Chronic Pancreatitis, Diabetes
- Keywords
- chronic pancreatitis, PPDM-C, CGM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 11 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
The purpose of this study was to explore the characteristics of blood glucose spectrum, changes of endocrine/exocrine pancreatic function and the correlation between them in patients with PPDM-C.
Detailed description
The benefits of this study to participants include:
- It will help to make early diagnosis or risk screening for the potential related risks and concomitant diseases of the disease;
- Provide necessary suggestions for the treatment and intervention of the disease, or provide useful information for the related research of the disease.
- We will provide Abbott version h dynamic glucose meter and assessment of internal and external secretion function. The researcher will provide professional endocrine related lifestyle and drug guidance for the subjects according to their CGMS data.
The risks that this study may bring to participants are:
There may be some very small risks in specimen collection, including transient pain, local cyanosis, etc. a few people will have mild dizziness or extremely rare needle infection.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic pancreatitis
Key inclusion criteria (3 listed)
- Male or female Chinese subjects;
Key exclusion criteria (5 listed)
- Patients with impaired glucose tolerance but undiagnosed diabetes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood glucose profile characteristics of patients with PPDM-C
Time frame: From February 2025 to December 2025
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 14 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Diabetes, run by Shanghai Changzheng Hospital.
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 5 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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood glucose profile characteristics of patients with PPDM-C (time frame: From February 2025 to December 2025). 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 14 Feb 2025.