Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Exocrine Pancreatic Insufficiency (EPI). Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol
Overview
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.
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.
Primary outcome measures
- Prevalence of pancreatogenic diabetes [Time frame: At single study visit (baseline)]
Secondary outcome measures (12)
- Fecal elastase-1 [Time frame: Baseline (single study visit)]
- Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) [Time frame: Baseline (single study visit)]
- C-peptide [Time frame: Baseline (single study visit)]
- Glycated hemoglobin (HbA1c) [Time frame: Baseline (single study visit)]
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: Baseline (single study visit)]
- Homeostatic Model Assessment of Beta-cell Function (HOMA-B) [Time frame: Baseline (single study visit)]
- Serum TGF-β1 [Time frame: Baseline (single study visit)]
- Serum adiponectin [Time frame: Baseline (single study visit)]
- Serum interleukin-1 receptor antagonist (IL-1RA) [Time frame: Baseline (single study visit)]
- Pancreatic ultrasound parameters- Pancreatic Size [Time frame: Baseline (single study visit)]
- Pancreatic ultrasound parameters - Pancreatic Echogenicity [Time frame: Baseline (single study visit)]]
- Pancreatic ultrasound parameters - Pancreatic Duct Features [Time frame: Baseline (single study visit)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Kazakhstan · 1 center
- Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University — Aktobe
Identifiers
NCT: NCT07512934 · T3cDM-KZ-Aktobe · 13/2-19-38-GTZh