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.
• 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
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;
kazakh population
Other
Cross-sectional
Not listed
Prevalence of pancreatogenic diabetes
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).
Fecal elastase-1
To assess exocrine pancreatic function by measuring fecal elastase-1 concentration (µg/g stool). Values are interpreted as follows: ≥200 µg/g indicates normal exocrine pancreatic function, 100-200 µg/g indicates mild to moderate exocrine pancreatic insufficiency, and \<100 µg/g indicates severe exocrine pancreatic insufficiency. Lower values indicate worse pancreatic exocrine function.
Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q)
The Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) is an 18-item patient-reported outcome instrument assessing symptoms and impacts of exocrine pancreatic insufficiency over the past 7 days. Each item is scored on a 5-point scale from 0 to 4. Domain scores (abdominal symptoms, bowel movements, and impacts) and total scores are calculated as mean values. Scores range from 0 to 4, with higher scores indicating more severe exocrine pancreatic insufficiency symptoms and greater impact on quality of life. A total symptom score ≥0.60 is considered suggestive of clinically relevant exocrine pancreatic insufficiency. Higher scores (e.g., ≥1.8) may indicate more severe or poorly controlled disease.
C-peptide
To assess pancreatic β-cell function by measuring fasting serum C-peptide levels (ng/mL). Lower levels indicate impaired β-cell function, whereas higher levels reflect preserved endogenous insulin secretion.
Glycated hemoglobin (HbA1c)
To evaluate glycemic control by measuring HbA1c levels (%).
Click on the lead sponsor to view all of their trials.
West Kazakhstan Marat Ospanov Medical University
Lead sponsor
Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
Collaborator