Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
ID: NCT07512934
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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.
Read Full Scientific Objectives & Methods
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.
Treatment Arms Description
Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to fecal elastase-1 levels.
Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) results.
- • 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;
- 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.
Primary Outcome Measures
- Prevalence of pancreatogenic diabetes — Time Frame: 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).
View Secondary Outcome Measures (13)
- Fecal elastase-1 — Time Frame: Baseline (single study visit)
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) — Time Frame: Baseline (single study visit)
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 — Time Frame: Baseline (single study visit)
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) — Time Frame: Baseline (single study visit)
To evaluate glycemic control by measuring HbA1c levels (%).
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) — Time Frame: Baseline (single study visit)
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.
- Homeostatic Model Assessment of Beta-cell Function (HOMA-B) — Time Frame: Baseline (single study visit)
To evaluate pancreatic β-cell function using the HOMA-B index calculated from fasting glucose and fasting insulin levels.
- Serum TGF-β1 — Time Frame: Baseline (single study visit)
To evaluate fibrotic activity and pancreatic remodeling by measuring serum TGF-β1 concentration (ng/mL).
- Serum adiponectin — Time Frame: Baseline (single study visit)
To assess metabolic regulation associated with pancreatic dysfunction by measuring adiponectin levels (ng/mL).
- Serum interleukin-1 receptor antagonist (IL-1RA) — Time Frame: Baseline (single study visit)
To evaluate inflammatory regulation related to pancreatic dysfunction by measuring IL-1RA levels (pg/mL).
- Pancreatic ultrasound parameters- Pancreatic Size — Time Frame: Baseline (single study visit)
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.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol