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Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests

NCT06006312 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2023-08-25

No results posted yet for this study

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.

Conditions

  • Chronic Pancreatitis
  • Pancreatic Exocrine Insufficiency
  • Diabetes Mellitus
  • Community Populations
  • Fecal Elastase-1 Test

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06006312 on ClinicalTrials.gov