Assessment of Pancreatic Dysfunction in Patients With Type 2 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).

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.

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.

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.

To evaluate glycemic control by measuring HbA1c levels (%).

Assessment of insulin resistance using the HOMA2-IR index in adults with newly diagnosed diabetes. HOMA2-IR calculated from fasting glucose and fasting insulin at diagnosis. No fixed minimum or maximum score; higher scores indicate worse insulin resistance. In published population-based studies of adults, thresholds for insulin resistance typically range from approximately 1.8 to 2.0.

To evaluate pancreatic β-cell function using the HOMA-B index calculated from fasting glucose and fasting insulin levels.

To evaluate fibrotic activity and pancreatic remodeling by measuring serum TGF-β1 concentration (ng/mL).

To assess metabolic regulation associated with pancreatic dysfunction by measuring adiponectin levels (ng/mL).

To evaluate inflammatory regulation related to pancreatic dysfunction by measuring IL-1RA levels (pg/mL).

To assess pancreatic size using ultrasound imaging by measuring the dimensions of the pancreatic head, body, and tail (mm). Reduced pancreatic size may indicate atrophy or chronic pancreatic damage, whereas enlargement may reflect inflammation or structural changes.

To assess pancreatic echogenicity using ultrasound imaging, categorized as normal, increased, or decreased relative to liver echogenicity. Increased echogenicity may indicate pancreatic fibrosis or fatty infiltration. Decreased echogenicity may suggest pancreatic edema or acute inflammatory changes. Normal echogenicity reflects preserved pancreatic tissue structure.

To assess pancreatic duct characteristics using ultrasound imaging, including duct diameter and structural features such as dilation or irregularity. Abnormal ductal features may indicate structural pancreatic pathology or chronic changes.

To exclude autoimmune diabetes by assessing anti-glutamic acid decarboxylase (GAD65) antibody status (positive/negative).