Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes (T3cDM-AKT)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Exocrine Pancreatic Insufficiency (EPI); Pancreatogenic Diabetes Mellitus

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Mengtay S Makashova; Phone Number: +77058440060; Email: ersultanbeknur@gmail.com

Study Locations

• Kazakhstan
  • Aktobe Region
    • Aktobe, Aktobe Region, Kazakhstan, 030019
      • Recruiting
      • Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University
      • Contact: Mengtay Makashova; Phone Number: 87058440060; Email: ersultanbeknur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

kazakh population

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group/Cohort Label T2DM without EPI by fecal elastase-1; Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to fecal elastase-1 levels.
Group/Cohort Label T2DM without EPI by PEI-Q; Adults with type 2 diabetes mellitus classified as not having exocrine pancreatic insufficiency according to Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At single study visit (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline (single study visit)
Glycated hemoglobin (HbA1c)	To evaluate glycemic control by measuring HbA1c levels (%).	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.	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.	Baseline (single study visit)
Serum TGF-β1	To evaluate fibrotic activity and pancreatic remodeling by measuring serum TGF-β1 concentration (ng/mL).	Baseline (single study visit)
Serum adiponectin	To assess metabolic regulation associated with pancreatic dysfunction by measuring adiponectin levels (ng/mL).	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).	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.	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.	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.	Baseline (single study visit)
Anti-GAD65 antibody	To exclude autoimmune diabetes by assessing anti-glutamic acid decarboxylase (GAD65) antibody status (positive/negative).	Baseline (single study visit)

Collaborators and Investigators

• Sponsor: West Kazakhstan Marat Ospanov Medical University
• Collaborators: Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Adiponectin; TGF-beta1; IL-1 receptor antagonist; Pancreatogenic diabetes; Type 3c diabetes; Fecal elastase-1; Pancreatic ultrasound; PEI-Q
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pancreatic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency; Camurati-Engelmann Syndrome
• Other Study ID Numbers: T3cDM-KZ-Aktobe; 13/2-19-38-GTZh (Other Grant/Funding Number: West Kazakhstan Marat Ospanov Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No