Chronic PancreatitisNCT05989867
Evaluation of OGTT in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization
An observational study of Chronic Pancreatitis and Pancreatogenic Type 3C Diabetes Mellitus, run by Changhai Hospital at 1 site in China.
Trial summary
To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Chronic Pancreatitis, Pancreatogenic Type 3C Diabetes Mellitus, Diabetes Mellitus
- What is being tested?
- blood test and Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital
Who may be able to join
- Age 15-85
- patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
- 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.
- patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.
Who cannot join
- Participants with suspected malignant tumors of the pancreas or other sites of the body (including pancreatic cyst and Benign pancreatic tumor), or participants in the terminal stage of severe disease
- Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
- Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate aminotransferase > 3 times the upper reference limit) or kidney (eGFR<60 mL/min/1.73 m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver diseases such as hepatitis B or hepatic cirrhosis.
- Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
- Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs, and antipsychotics)
- Acute complications of diabetes (diabetic ketoacidosis, severe hypoglycemia), severe microvascular disease (proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment), and macrovascular disease (uncontrolled arterial hypertension, uncontrolled coronary artery disease, congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation) within the 12 months prior to enrollment.
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- Hospitalization for acute pancreatitis within the 2 months prior to enrollment or currently suffering acute inflammation.
- Have been enrolled or currently participating in other clinical trials within the 3 months prior to enrollment.
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
zhuan liao, MD, 86-21-31161004, liaozhuan@smmu.edu.cn
About this study
Official title: Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial
To evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.
Read the detailed description
Blood samples will be collected from patients with chronic pancreatitis by oral glucose tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites, and serum biochemical factors to characterize the pathophysiological features of PPDM-C and provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic fluctuations in patients with chronic pancreatitis combined with diabetes and guide subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic pancreatitis who had new-onset diabetes or poor glycemic control.
- Conditions
- Chronic Pancreatitis, Pancreatogenic Type 3C Diabetes Mellitus, Diabetes Mellitus, Oral Glucose Tolerance Test
- Being tested
- blood test, Continuous Glucose Monitor
- 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
Evaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis.
Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors
Continuous Glucose MonitorDevice
blood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control )
| Study group | Role | What they receive |
|---|---|---|
| CP | patients with chronic pancreatitis but not combined with diabetes Receives: Diagnostic Test: blood test | |
| PPDM-C | patients with post-chronic pancreatitis diabetes mellitus Receives: Diagnostic Test: blood test; Device: Continuous Glucose Monitor | |
| CP+IGT | patients with chronic pancreatitis combined with impaired glucose tolerance Receives: Diagnostic Test: blood test; Device: Continuous Glucose Monitor | |
| CP+T2DM | patients with chronic pancreatitis combined with type 2 diabetes mellitus Receives: Diagnostic Test: blood test; Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
steamed bun meal test result 1
Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)
Measured: Within 5 hours after the end of the steamed bread meal test
steamed bun meal test result 2
Levels of c-peptide bun meal experiment (100g flour made steamed bun)
Measured: Within 6 hours after the end of the steamed bread meal test
steamed bun meal test result 3
Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)
Measured: Within 7 hours after the end of the steamed bread meal test
Secondary outcomes (3)
gut hormone
Levels of gut hormone under the steamed bun meal experiment (100g flour made steamed bun)
Measured: up to 1 month
Continuous glucose monitor results
Time to target range (TIR) : the proportion of time with blood glucose fluctuation
Measured: after using continuous glucose monitor device for 7-14 days
glycemic control
glycosylated hemoglobin（%）
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Mar 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
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
- NCT05989867
- Sponsor's protocol ID
- ESTABLISH
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Glucose Tolerance Testing in Patients With Post-pancreatitis Diabetes Mellitus for Diagnosis and Characterization: a Cross-sectional Trial
- ClinicalTrials.gov ID
- NCT05989867
- Acronym / sponsor ID
- ESTABLISH
- Conditions
- Chronic Pancreatitis, Pancreatogenic Type 3C Diabetes Mellitus, Diabetes Mellitus, Oral Glucose Tolerance Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 14 Aug 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 evaluate the islet function and insulin secretion pattern of post-pancreatitis diabetes mellitus by oral glucose tolerance testing, and to explore the pathophysiological characteristics of PPDM-C which provide evidence for the diagnosis of PPDM-C.
Detailed description
Blood samples will be collected from patients with chronic pancreatitis by oral glucose tolerance test (steamed bun meal test, SBMT) to assess their pancreatic islet function and insulin secretion pattern, measure other intestinal hormones, exosomes, plasma metabolites, and serum biochemical factors to characterize the pathophysiological features of PPDM-C and provide evidence for the diagnosis of PPDM-C. In order to better understand the glycemic fluctuations in patients with chronic pancreatitis combined with diabetes and guide subsequent treatment, Continuous Glucose Monitoring would be used in patients with chronic pancreatitis who had new-onset diabetes or poor glycemic control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CP | – | Diagnostic Test: blood testpatients with chronic pancreatitis but not combined with diabetes |
| PPDM-C | – | Diagnostic Test: blood test, Device: Continuous Glucose Monitorpatients with post-chronic pancreatitis diabetes mellitus |
| CP+IGT | – | Diagnostic Test: blood test, Device: Continuous Glucose Monitorpatients with chronic pancreatitis combined with impaired glucose tolerance |
| CP+T2DM | – | Diagnostic Test: blood test, Device: Continuous Glucose Monitorpatients with chronic pancreatitis combined with type 2 diabetes mellitus |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic pancreatitis treated in the Department of Gastroenterology of Changhai Hospital
Key inclusion criteria (5 listed)
- Age 15-85
- patients with the diagnosis of chronic pancreatitis and diabetes mellitus (exclude type 1 diabetes).
- 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.
- patients with chronic pancreatitis were previously diagnosed type 2 diabetes mellitus for more than 3 years.
Key exclusion criteria (9 listed)
- Participants with suspected malignant tumors of the pancreas or other sites of the body (including pancreatic cyst and Benign pancreatic tumor), or participants in the terminal stage of severe disease
- Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreatojejunostomy, or Frey), and prior bariatric or gastrointestinal surgery.
- Serious mental illness, lesion of the liver (alanine aminotransferase or aspartate aminotransferase > 3 times the upper reference limit) or kidney (eGFR<60 mL/min/1.73 m2), pregnancy, breastfeeding or planning pregnancy, or accompanied with active liver diseases such as hepatitis B or hepatic cirrhosis.
- Diagnosed type 1 diabetes, or other metabolic diseases that affect blood glucose
- Using high-dose insulin preparations, or drugs affecting glucose metabolism (oral steroids, thiazide diuretics, beta-blockers, beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs, and antipsychotics)
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 testEvaluation of islets function and insulin secretion pattern： Evaluating the venous plasma glucose, c-peptide, and insulin concentrations at 0h, 0.5h, 1h, 2h, and 3h after the SBMT in patients with chronic pancreatitis. Characterization of pathophysiological features： Measuring intestinal hormones, exosomes, serum metabolites, and serum biochemical factors | Diagnostic test | CP, CP+IGT, CP+T2DM, PPDM-C |
| Continuous Glucose Monitorblood glucose will be monitored 24 hours a day from 7 to 14 days by wearing continuous glucose monitor(only for patients who had new-onset diabetes or poor glycemic control ) | Device | CP+IGT, CP+T2DM, PPDM-C |
Primary outcome
steamed bun meal test result 1
Time frame: Within 5 hours after the end of the steamed bread meal test
Levels of glucose under the steamed bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 2
Time frame: Within 6 hours after the end of the steamed bread meal test
Levels of c-peptide bun meal experiment (100g flour made steamed bun)
steamed bun meal test result 3
Time frame: Within 7 hours after the end of the steamed bread meal test
Levels of insulin under the steamed bun meal experiment (100g flour made steamed bun)
3 secondary outcomes
gut hormone
Time frame: up to 1 month
Continuous glucose monitor results
Time frame: after using continuous glucose monitor device for 7-14 days
glycemic control
Time frame: at the time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
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 Pancreatogenic Type 3C 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Liao (13061921980, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
steamed bun meal test result 1 (time frame: Within 5 hours after the end of the steamed bread meal test). The study lists 3 primary outcomes in all. 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 Aug 2023.