Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes

Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol

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.

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.

Inclusion Criteria:

• • 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

Exclusion Criteria:

• 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.