An observational study in Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM) and Exocrine Pancreatic Insufficiency (EPI), sponsored by West Kazakhstan Marat Ospanov Medical University. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by West Kazakhstan Marat Ospanov Medical University · Observational
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:
Participants will:
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 310 is close to the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →West Kazakhstan Marat Ospanov Medical University is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
kazakh population
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: At single study visit (baseline)
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.
Time frame: Baseline (single study visit)
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.
Time frame: Baseline (single study visit)
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.
Time frame: Baseline (single study visit)
Glycated hemoglobin (HbA1c)
To evaluate glycemic control by measuring HbA1c levels (%).
Time frame: Baseline (single study visit)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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.
Time frame: Baseline (single study visit)
Homeostatic Model Assessment of Beta-cell Function (HOMA-B)
To evaluate pancreatic β-cell function using the HOMA-B index calculated from fasting glucose and fasting insulin levels.
Time frame: Baseline (single study visit)
Serum TGF-β1
To evaluate fibrotic activity and pancreatic remodeling by measuring serum TGF-β1 concentration (ng/mL).
Time frame: Baseline (single study visit)
Serum adiponectin
To assess metabolic regulation associated with pancreatic dysfunction by measuring adiponectin levels (ng/mL).
Time frame: Baseline (single study visit)
Serum interleukin-1 receptor antagonist (IL-1RA)
To evaluate inflammatory regulation related to pancreatic dysfunction by measuring IL-1RA levels (pg/mL).
Time frame: Baseline (single study visit)
Pancreatic ultrasound parameters- Pancreatic Size
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.
Time frame: Baseline (single study visit)
Pancreatic ultrasound parameters - Pancreatic Echogenicity
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.
Time frame: Baseline (single study visit)]
Pancreatic ultrasound parameters - Pancreatic Duct Features
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.
Time frame: Baseline (single study visit)
Anti-GAD65 antibody
To exclude autoimmune diabetes by assessing anti-glutamic acid decarboxylase (GAD65) antibody status (positive/negative).
Time frame: Baseline (single study visit)
Plan to share: Undecided — The plan to share individual participant data has not yet been determined. Future data sharing will be considered in accordance with institutional policies, ethical guidelines, and applicable regulations.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
West Kazakhstan Marat Ospanov Medical University