Detecting pancreatic dysfunction in adults with type 2 diabetes
Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol
This project tests whether blood tests, a stool sample, and an ultrasound can identify pancreatogenic diabetes in adults with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 310 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | West Kazakhstan Marat Ospanov Medical University Academic / other |
| Locations | 1 site (Aktobe, Aktobe) |
| Trial ID | NCT07512934 on ClinicalTrials.gov |
What this trial studies
This cross-sectional, single-visit study in outpatient clinics in the Aktobe region of Kazakhstan enrolls adults with type 2 diabetes of up to five years' duration and conducts a standardized evaluation of pancreatic endocrine and exocrine function. Participants provide blood for glucose, insulin, adiponectin, TGF-beta1 and other markers, a stool sample for fecal elastase-1, complete a digestive-symptom questionnaire, and undergo pancreatic ultrasound. Recruitment is consecutive across multiple regional outpatient sites coordinated by West Kazakhstan Marat Ospanov Medical University. No treatments are given as part of the visit; collected data will be analyzed to see how blood markers and imaging relate to pancreatic function and the presence of pancreatogenic diabetes.
Who should consider this trial
Good fit: Adults aged 18–74 of Kazakh nationality with type 2 diabetes diagnosed per ADA criteria, disease duration ≤5 years, and no recent ketoacidosis or positive anti-GAD65 are ideal candidates.
Not a fit: Patients with long-standing diabetes, known type 1 diabetes or other specific diabetes types, recent infections, active malignancy, systemic fibrosis, pregnancy, or who cannot attend Aktobe outpatient clinics are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help diagnose pancreatogenic diabetes earlier and guide more appropriate treatment for affected patients.
How similar studies have performed: Previous work has shown fecal elastase and imaging can detect exocrine dysfunction in subsets of patients, but integrated single-visit panels combining blood markers, stool elastase, and ultrasound remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aktobe, Aktobe
- Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University — Aktobe, Aktobe, Kazakhstan (Recruiting)
Study contacts
- Study coordinator: Mengtay S Makashova
- Email: ersultanbeknur@gmail.com
- Phone: +77058440060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.