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临床试验/NCT06006312
NCT06006312招募中不适用

Establishment and Clinical Application of Pancreatic Endocrine and Exocrine Function Tests

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2023年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,400
试验地点
1
主要终点
the prevalence of pancreatic exocrine insufficiency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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:
  • Inclusion Criteria:
  • Patients with chronic pancreatitis.
  • Age between 18 and 80 years.
  • Exclusion Criteria:
  • 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:
  • Inclusion Criteria (meet 1 or 2):
  • Patients with chronic pancreatitis and diabetes mellitus.
  • Patients with type 2 diabetes mellitus.
  • Exclusion Criteria:
  • Patients with type 2 diabetes mellitus.
  • Participants in critical condition.
  • Have mental disorders and unable cooperate with investigators.

结局指标

主要结局

the prevalence of pancreatic exocrine insufficiency

时间窗: 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.

次要结局

  • Concentration of Glycosylated hemoglobin(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)
  • Concentration of plasma glucose(1 day after each participant collected blood sample)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Professor

Changhai Hospital

研究点 (1)

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