Chronic PancreatitisNCT06006312
Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
An observational study of Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this observational study is to improve the epidemiological data of pancreatic exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in clinical symptoms and laboratory indicators. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency, Diabetes Mellitus
- What is being tested?
- fecal elastase-1 test, 72-hour fecal fat quantification and blood sample test
- Type of treatment
- Pill or oral medicine
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Elderly participants will be recruited from several nursing homes. Community participants will be recruited from the community in Shanghai, China. Patients whti chronic pancreatitis and type 2 diabetes mellitus come from Changhai Hospital, Ruijin Hospital and Shanghai General Hospital.
Who may be able to join
- Agree to participate in the study and sign the informed consent.
- Age of elderly participants are over 60 years old and the participants from community is unlimited.
- Patients with chronic pancreatitis.
- Age between 18 and 80 years.
- Patients with chronic pancreatitis and diabetes mellitus.
- Patients with type 2 diabetes mellitus.
Who cannot join
- Participants in critical condition.
- Have mental disorders and unable cooperate with investigators.
- Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
- For chronic pancreatitis patients:
- Pregnant or breastfeeding women
- Participants in critical condition.
Show all 14Show fewer
- Have mental disorders and unable cooperate with investigators.
- Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
- Fecal sample quality, storage and transportation do not meet the requirements of fecal elastase-1 test.
- Have undergone gastrectomy or pancreatectomy more than once.
- For chronic pancreatitis patients with diabetes and patients with type 2 diabetes mellitus:
- Patients with type 2 diabetes mellitus.
- Participants in critical condition.
- Have mental disorders and unable cooperate with investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Liang-hao Hu, MD, +86-13817593520, lianghao-hu@smmu.edu.cn
Zhao-shen Li, MD, +86-13901960921, zhaoshen-li@hotmail.com
About this study
The goal of this observational study is to improve the epidemiological data of pancreatic exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in clinical symptoms and laboratory indicators.
Read the detailed description
Pancreatic exocrine insufficiency (PEI) refers to the reduction in the synthesis and secretion of pancreatic enzymes caused by various reasons, which leads to malabsorption and even nutritional deficiencies. The main causes of PEI include chronic pancreatitis (CP), acute pancreatitis, pancreatic cancer, pancreatectomy, enterectomy, diabetes mellitus and cystic fibrosis. Due to its numerous etiologies, the current prevalence of PEI is uncertain and very varied. The prevalence of PEI in the Chinese population is still lacking. Diagnosis of PEI in clinical practice is hindered by the lack of accurate tests, and it usually requires the combination of symptoms, nutritional markers and a noninvasive pancreatic function test in the appropriate clinical context. At present, the fecal elastase-1 (FE-1) test is the most widely applied non-invasive approach in routine clinical practice.
First, the study plans to record the baseline data of participants and perform the FE-1 test in specific elderly population and community population, in order to improve the epidemiology of PEI in China.
Second, the study will perform the FE-1 test in 100 CP patients, in order to determine the FE-1 cut-off value for the classification of PEI (mild-moderate and severe), using the coefficient of fat absorption as the "gold standard".
Third, people with CP often have diabetes mellitus which is described as type 3c diabetes mellitus (T3cDM). However, there are no recognized diagnostic criteria for T3cDM. Studies have shown that close to 50% of T3cDM cases are misclassified, most of which are diagnosed as type 2 diabetes mellitus (T2DM). According to certain research, the early stages of T3cDM are characterized by insufficient insulin and C-peptide secretion. The study will provide laboratory testing to 300 patients with T3cDM and T2DM in order to compare the differences and create T3cDM diagnostic criteria.
- Conditions
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency, Diabetes Mellitus, Community Populations, Fecal Elastase-1 Test
- Being tested
- fecal elastase-1 test, 72-hour fecal fat quantification, blood sample test
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal elastase-1 testDiagnostic test
Personal information of the enrolled subjects will be collected and a fecal collection device will be distributed. Fecal elastase-1 levels will be measured after the fecal sample is collected.
72-hour fecal fat quantificationDiagnostic test
Enrolled subjects will eat a standard meal (100g of fat) daily for five consecutive days and collect stool samples for the last 72h. The fat content in the sample will be quantitatively detected and the fat absorption coefficient will be calculated.
blood sample testDiagnostic test
Also called oral glucose tolerance test
The enrolled subjects will undergo oral glucose tolerance test and will be collected blood samples for measurement of plasma glucose, insulin level, C-peptide level, glycosylated hemoglobin and vitamin.
| Study group | Role | What they receive |
|---|---|---|
| Elderly population | The elderly population is defined as those over 60 years of age and residing in retirement home. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses. Receives: Diagnostic Test: fecal elastase-1 test | |
| Community population | This group is the resident population of the community. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses. Receives: Diagnostic Test: fecal elastase-1 test | |
| Chronic pancreatitis | Patients with chronic pancreatitis are considered as study subjects. If a CP patient has diabetes mellitus (exclude type 1 diabetes mellitus), a blood test will be performed to assess glycemic control. Receives: Diagnostic Test: fecal elastase-1 test; Diagnostic Test: 72-hour fecal fat quantification; Diagnostic Test: blood sample test | |
| Type 2 diabetes mellitus | Patients with type 2 diabetes mellitus are considered as study subjects. Receives: Diagnostic Test: fecal elastase-1 test; Diagnostic Test: blood sample test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of pancreatic exocrine insufficiency
Prevalence of pancreatic exocrine insufficiency (mild-moderate, sever) which is dependent on FE-1 level assessment in elderly population and community population respectively.
Measured: 7 days after each participant collected stool samples
Secondary outcomes (4)
Concentration of Glycosylated hemoglobin
Compare the concentration of glycosylated hemoglobin in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
Measured: 1 day after each participant collected blood sample
Concentration of plasma glucose
During oral glucose tolerance test, concentration of plasma glucose (fasting and 2-hour) will be measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
Measured: 1 day after each participant collected blood sample
C-peptide level
During oral glucose tolerance test, C-peptide levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
Measured: 1 day after each participant collected blood sample
Insulin level
During oral glucose tolerance test, insulin levels (fasting and 2-hour) are measured in chronic pancreatitis patients with diabetes mellitus and participants with type 2 diabetes mellitus.
Measured: 1 day after each participant collected blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006312
- Sponsor's protocol ID
- SHDC12021107
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
- ClinicalTrials.gov ID
- NCT06006312
- Acronym / sponsor ID
- SHDC12021107
- Conditions
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency, Diabetes Mellitus, Community Populations, Fecal Elastase-1 Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- Aug 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 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.
The goal of this observational study is to improve the epidemiological data of pancreatic exocrine insufficiency in China, determine the FE-1 cut-off value for the classification of PEI, and explore the characteristic differences between T3cDM and type 2 diabetes mellitus in clinical symptoms and laboratory indicators.
Detailed description
Pancreatic exocrine insufficiency (PEI) refers to the reduction in the synthesis and secretion of pancreatic enzymes caused by various reasons, which leads to malabsorption and even nutritional deficiencies. The main causes of PEI include chronic pancreatitis (CP), acute pancreatitis, pancreatic cancer, pancreatectomy, enterectomy, diabetes mellitus and cystic fibrosis. Due to its numerous etiologies, the current prevalence of PEI is uncertain and very varied. The prevalence of PEI in the Chinese population is still lacking. Diagnosis of PEI in clinical practice is hindered by the lack of accurate tests, and it usually requires the combination of symptoms, nutritional markers and a noninvasive pancreatic function test in the appropriate clinical context. At present, the fecal elastase-1 (FE-1) test is the most widely applied non-invasive approach in routine clinical practice.
First, the study plans to record the baseline data of participants and perform the FE-1 test in specific elderly population and community population, in order to improve the epidemiology of PEI in China.
Second, the study will perform the FE-1 test in 100 CP patients, in order to determine the FE-1 cut-off value for the classification of PEI (mild-moderate and severe), using the coefficient of fat absorption as the "gold standard".
Third, people with CP often have diabetes mellitus which is described as type 3c diabetes mellitus (T3cDM). However, there are no recognized diagnostic criteria for T3cDM. Studies have shown that close to 50% of T3cDM cases are misclassified, most of which are diagnosed as type 2 diabetes mellitus (T2DM). According to certain research, the early stages of T3cDM are characterized by insufficient insulin and C-peptide secretion. The study will provide laboratory testing to 300 patients with T3cDM and T2DM in order to compare the differences and create T3cDM diagnostic criteria.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elderly population | – | Diagnostic Test: fecal elastase-1 testThe elderly population is defined as those over 60 years of age and residing in retirement home. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses. |
| Community population | – | Diagnostic Test: fecal elastase-1 testThis group is the resident population of the community. Excluding people with critical conditions, mental disorders that prevent them from cooperating with the study, and those who are unable to defecate due to intestinal obstruction or other illnesses. |
| Chronic pancreatitis | – | Diagnostic Test: fecal elastase-1 test, Diagnostic Test: 72-hour fecal fat quantification, Diagnostic Test: blood sample testPatients with chronic pancreatitis are considered as study subjects. If a CP patient has diabetes mellitus (exclude type 1 diabetes mellitus), a blood test will be performed to assess glycemic control. |
| Type 2 diabetes mellitus | – | Diagnostic Test: fecal elastase-1 test, Diagnostic Test: blood sample testPatients with type 2 diabetes mellitus are considered as study subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elderly participants will be recruited from several nursing homes. Community participants will be recruited from the community in Shanghai, China. Patients whti chronic pancreatitis and type 2 diabetes mellitus come from Changhai Hospital, Ruijin Hospital and Shanghai General Hospital.
Key inclusion criteria (6 listed)
- Agree to participate in the study and sign the informed consent.
- Age of elderly participants are over 60 years old and the participants from community is unlimited.
- Patients with chronic pancreatitis.
- Age between 18 and 80 years.
- Patients with chronic pancreatitis and diabetes mellitus.
Key exclusion criteria (14 listed)
- Participants in critical condition.
- Have mental disorders and unable cooperate with investigators.
- Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
- Pregnant or breastfeeding women
- Participants in critical condition.
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 |
|---|---|---|
| fecal elastase-1 testPersonal information of the enrolled subjects will be collected and a fecal collection device will be distributed. Fecal elastase-1 levels will be measured after the fecal sample is collected. | Diagnostic test | Chronic pancreatitis, Community population, Elderly population, Type 2 diabetes mellitus |
| 72-hour fecal fat quantificationEnrolled subjects will eat a standard meal (100g of fat) daily for five consecutive days and collect stool samples for the last 72h. The fat content in the sample will be quantitatively detected and the fat absorption coefficient will be calculated. | Diagnostic test | Chronic pancreatitis |
| blood sample testAlso: oral glucose tolerance testThe enrolled subjects will undergo oral glucose tolerance test and will be collected blood samples for measurement of plasma glucose, insulin level, C-peptide level, glycosylated hemoglobin and vitamin. | Diagnostic test | Chronic pancreatitis, Type 2 diabetes mellitus |
Primary outcome
the prevalence of pancreatic exocrine insufficiency
Time frame: 7 days after each participant collected stool samples
Prevalence of pancreatic exocrine insufficiency (mild-moderate, sever) which is dependent on FE-1 level assessment in elderly population and community population respectively.
4 secondary outcomes
Concentration of Glycosylated hemoglobin
Time frame: 1 day after each participant collected blood sample
Concentration of plasma glucose
Time frame: 1 day after each participant collected blood sample
C-peptide level
Time frame: 1 day after each participant collected blood sample
Insulin level
Time frame: 1 day after each participant collected blood sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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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 Pancreatic Exocrine Insufficiency, 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 6 inclusion and 14 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 25 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 Liang-hao Hu, MD (+86-13817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of pancreatic exocrine insufficiency (time frame: 7 days after each participant collected stool samples). 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 25 Aug 2023.