Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests
1 other identifier
observational
2,400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 25, 2023
August 1, 2023
3 months
August 17, 2023
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
7 days after each participant collected stool samples
Secondary Outcomes (4)
Concentration of Glycosylated hemoglobin
1 day after each participant collected blood sample
Concentration of plasma glucose
1 day after each participant collected blood sample
C-peptide level
1 day after each participant collected blood sample
Insulin level
1 day after each participant collected blood sample
Study Arms (4)
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.
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.
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.
Type 2 diabetes mellitus
Patients with type 2 diabetes mellitus are considered as study subjects.
Interventions
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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:
- Patients with chronic pancreatitis.
- Age between 18 and 80 years.
- Pregnant or breastfeeding women
- 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.
- 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 chronic pancreatitis and diabetes mellitus.
- Patients with type 2 diabetes mellitus.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- Ruijin Hospitalcollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
Study Sites (1)
Changhai Hospital
Shanghai, 200433, China
Biospecimen
feces
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 23, 2023
Study Start
August 1, 2023
Primary Completion
November 1, 2023
Study Completion
December 1, 2023
Last Updated
August 25, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share