Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Prevalence of pancreatogenic diabetes
研究概览
简要总结
The goal of this observational study is to better understand how the pancreas works in adults with type 2 diabetes. The study focuses on both hormone production (endocrine function) and digestive function (exocrine function) of the pancreas.
The main questions it aims to answer are:
- Can problems with the pancreas help identify a different type of diabetes called pancreatogenic diabetes?
- How are blood markers and pancreas structure related to pancreatic function?
Participants will:
- Have blood tests to measure glucose, insulin, and other markers
- Provide a stool sample to assess digestive function
- Undergo an ultrasound examination of the pancreas
- Answer questions about digestive symptoms
The study will take place during a single visit in outpatient clinics.
详细描述
Type 2 diabetes mellitus (T2DM) is a heterogeneous disorder that may overlap with pancreatogenic diabetes, a form characterized by combined endocrine and exocrine pancreatic dysfunction and frequent misclassification in clinical practice. Current diagnostic approaches are limited, as commonly used markers and imaging methods often detect pancreatic abnormalities only at advanced stages.
The aim of this study is to improve the identification of pancreatogenic diabetes through an integrated assessment of pancreatic function.
This study is designed as a cross-sectional, single-region, multisite investigation conducted in outpatient healthcare settings in the Aktobe region, Kazakhstan. Adult participants with type 2 diabetes of up to 5 years' duration will be consecutively recruited and will undergo a standardized single-visit assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• adult patients of Kazakh nationality aged 18 to 74 years
- •diagnosis of T2DM established according to ADA criteria and documented in medical records
- •disease duration ≤5 years
- •absence of ketoacidosis episodes within the last 6 months
排除标准
- •positive anti-glutamic acid decarboxylase antibodies (anti-GAD65);
- •acute or chronic infections affecting metabolic status within the previous 4 weeks;
- •any history of malignant neoplasms;
- •pregnancy or lactation;
- •previously diagnosed type 1 diabetes mellitus or other specific types of diabetes;
- •severe decompensated chronic diseases;
- •conditions associated with systemic fibrosis (e.g., liver cirrhosis or autoimmune diseases);
- •refusal to participate.
研究组 & 干预措施
Group/Cohort Label T2DM without EPI by PEI-Q
Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) results.
Group/Cohort Label T2DM without EPI by fecal elastase-1
Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to fecal elastase-1 levels.
结局指标
主要结局
Prevalence of pancreatogenic diabetes
时间窗: At single study visit (baseline)
Proportion of participants with type 2 diabetes mellitus meeting predefined criteria of pancreatogenic diabetes based on integrated assessment of pancreatic function (fecal elastase-1, pancreatic ultrasound findings, absence of autoimmune markers, and impaired β-cell function).
次要结局
- Fecal elastase-1(Baseline (single study visit))
- Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)(Baseline (single study visit))
- C-peptide(Baseline (single study visit))
- Glycated hemoglobin (HbA1c)(Baseline (single study visit))
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline (single study visit))
- Homeostatic Model Assessment of Beta-cell Function (HOMA-B)(Baseline (single study visit))
- Serum TGF-β1(Baseline (single study visit))
- Serum adiponectin(Baseline (single study visit))
- Serum interleukin-1 receptor antagonist (IL-1RA)(Baseline (single study visit))
- Pancreatic ultrasound parameters- Pancreatic Size(Baseline (single study visit))
- Pancreatic ultrasound parameters - Pancreatic Echogenicity(Baseline (single study visit)])
- Pancreatic ultrasound parameters - Pancreatic Duct Features(Baseline (single study visit))
- Anti-GAD65 antibody(Baseline (single study visit))
研究者
Mengtay Makashova
phd candidate
West Kazakhstan Marat Ospanov Medical University