Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
NCT ID: NCT06006312
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2400 participants
OBSERVATIONAL
2023-08-31
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
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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.
fecal elastase-1 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.
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.
fecal elastase-1 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.
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.
fecal elastase-1 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 quantification
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 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.
Type 2 diabetes mellitus
Patients with type 2 diabetes mellitus are considered as study subjects.
fecal elastase-1 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.
blood sample 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.
Interventions
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fecal elastase-1 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 quantification
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age of elderly participants are over 60 years old and the participants from community is unlimited.
1. Patients with chronic pancreatitis.
2. Age between 18 and 80 years.
1. Patients with chronic pancreatitis and diabetes mellitus.
2. Patients with type 2 diabetes mellitus.
Exclusion Criteria
2. Have mental disorders and unable cooperate with investigators.
3. Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
For chronic pancreatitis patients:
1. Pregnant or breastfeeding women
2. Participants in critical condition.
3. Have mental disorders and unable cooperate with investigators.
4. Have received bladder replacement with ileocolon surgery, or have intestinal obstruction and other diseases that can not defecate.
5. Fecal sample quality, storage and transportation do not meet the requirements of fecal elastase-1 test.
6. Have undergone gastrectomy or pancreatectomy more than once.
For chronic pancreatitis patients with diabetes and patients with type 2 diabetes mellitus:
1. Patients with type 2 diabetes mellitus.
2. Participants in critical condition.
3. Have mental disorders and unable cooperate with investigators.
ALL
Yes
Sponsors
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Ruijin Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Professor
Locations
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Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHDC12021107
Identifier Type: -
Identifier Source: org_study_id
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