Pancreatogenic Diabetes MellitusT3cDM-AKTNCT07512934
Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
An observational study of Pancreatogenic Diabetes Mellitus and Type 2 Diabetes Mellitus (T2DM), run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Exocrine Pancreatic Insufficiency (EPI)
- How many people
- 310 participants
- Where
- 1 siteKazakhstan
- Study dates
- 7 Jul 2025to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: kazakh population
Who may be able to join
- • 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University
Aktobe, Aktobe, 030019
Mengtay Makashova, 87058440060, ersultanbeknur@gmail.com
About this study
Official title: 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:
Read more
- 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 the 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.
- Conditions
- Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Exocrine Pancreatic Insufficiency (EPI)
- Keywords
- Type 3c diabetes, Pancreatogenic diabetes, Fecal elastase-1, TGF-beta1, Adiponectin, IL-1 receptor antagonist, Pancreatic ultrasound, PEI-Q, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At single study visit (baseline)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Glycated hemoglobin (HbA1c)
To evaluate glycemic control by measuring HbA1c levels (%).
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Serum TGF-β1
To evaluate fibrotic activity and pancreatic remodeling by measuring serum TGF-β1 concentration (ng/mL).
Measured: Baseline (single study visit)
Serum adiponectin
To assess metabolic regulation associated with pancreatic dysfunction by measuring adiponectin levels (ng/mL).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Anti-GAD65 antibody
To exclude autoimmune diabetes by assessing anti-glutamic acid decarboxylase (GAD65) antibody status (positive/negative).
Measured: Baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start7 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatogenic Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Kazakhstan Marat Ospanov Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
- Responsible party
- Principal investigator, Mengtay Makashova, West Kazakhstan Marat Ospanov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512934
- Sponsor's protocol ID
- T3cDM-KZ-Aktobe
- Other IDs
- 13/2-19-38-GTZh
- Acronym
- T3cDM-AKT
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.