Actively Recruiting

Age: 18Years - 74Years
All Genders
ID07512934

Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol

Led by West Kazakhstan Marat Ospanov Medical University · Updated on 2026-04-06

310

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

W

West Kazakhstan Marat Ospanov Medical University

Lead Sponsor

U

Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating pancreatic function in adults with type 2 diabetes to better understand both hormone production and digestive processes. This observational study aims to identify whether pancreatic problems can help detect pancreatogenic diabetes and how blood markers and pancreas structure relate to pancreatic function. The study is conducted as a cross-sectional, single-region, multisite investigation in outpatient clinics in the Aktobe region, Kazakhstan, focusing on adults with type 2 diabetes diagnosed within the past five years. Participants will attend a single visit during which blood tests will measure glucose, insulin, and other relevant markers. They will provide a stool sample to evaluate digestive function and undergo ultrasound imaging of the pancreas. Additionally, participants will answer questions about digestive symptoms to assess pancreatic exocrine function. The study groups include adults with type 2 diabetes who do not have exocrine pancreatic insufficiency based on fecal elastase-1 levels or questionnaire results. During the visit, researchers will collect and analyze various biochemical and imaging data, including fecal elastase-1, pancreatic ultrasound parameters, and blood markers such as C-peptide and glycated hemoglobin. Outcome measures will focus on the prevalence of pancreatogenic diabetes at the baseline visit. The study does not involve treatment but aims to improve diagnostic understanding through these comprehensive assessments. Total participation involves this single outpatient visit with no further follow-up required.

CONDITIONS

Brief Title

Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients of Kazakh nationality aged 18 to 74 years
  • Diagnosis of type 2 diabetes mellitus established according to ADA criteria and documented in medical records
  • Duration of type 2 diabetes of 5 years or less
  • No episodes of ketoacidosis within the last 6 months
Not Eligible

You will not qualify if you...

  • 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 such as liver cirrhosis or autoimmune diseases
  • Refusal to participate

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Single study visit

Participants undergo a standardized single-visit assessment including questionnaires, blood tests, and pancreatic ultrasound to evaluate pancreatic function and identify pancreatogenic diabetes.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University

Aktobe, Aktobe, Kazakhstan, 030019

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Research Team

M

Mengtay S Makashova

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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