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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.

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Sites and contacts
Official record

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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
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.

Mengtay S Makashova contact

+77058440060

ersultanbeknur@gmail.com

Kazakhstan1 site, 1 recruiting
  • Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University

    Aktobe, Aktobe, 030019

    Mengtay Makashova, 87058440060, ersultanbeknur@gmail.com

    Recruiting

Other trials in Kazakhstan

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.

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 groups in NCT07512934
Study groupRoleWhat they receive
Group/Cohort Label T2DM without EPI by fecal elastase-1Adults 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-QAdults 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. Glycated hemoglobin (HbA1c)

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

    Measured: Baseline (single study visit)

  5. 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)

  6. 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)

  7. Serum TGF-β1

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

    Measured: Baseline (single study visit)

  8. Serum adiponectin

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

    Measured: Baseline (single study visit)

  9. 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)

  10. 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)

  11. 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)]

  12. 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)

  13. 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.

  1. First posted6 Apr 2026
  2. Study start7 Jul 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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.

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