Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Pancreatogenic Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Exocrine Pancreatic Insufficiency (EPI). Базовые параметры: 18 лет — 74 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Казахстан
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Integrated Assessment of Pancreatic Dysfunction in Patients With Type 2 Diabetes: a Cross-sectional Study Protocol
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Prevalence of pancreatogenic diabetes [Срок оценки: At single study visit (baseline)]
Вторичные конечные точки (12)
- Fecal elastase-1 [Срок оценки: Baseline (single study visit)]
- Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) [Срок оценки: Baseline (single study visit)]
- C-peptide [Срок оценки: Baseline (single study visit)]
- Glycated hemoglobin (HbA1c) [Срок оценки: Baseline (single study visit)]
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Срок оценки: Baseline (single study visit)]
- Homeostatic Model Assessment of Beta-cell Function (HOMA-B) [Срок оценки: Baseline (single study visit)]
- Serum TGF-β1 [Срок оценки: Baseline (single study visit)]
- Serum adiponectin [Срок оценки: Baseline (single study visit)]
- Serum interleukin-1 receptor antagonist (IL-1RA) [Срок оценки: Baseline (single study visit)]
- Pancreatic ultrasound parameters- Pancreatic Size [Срок оценки: Baseline (single study visit)]
- Pancreatic ultrasound parameters - Pancreatic Echogenicity [Срок оценки: Baseline (single study visit)]]
- Pancreatic ultrasound parameters - Pancreatic Duct Features [Срок оценки: Baseline (single study visit)]
Критерии участия
Критерии включения
- • 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Казахстан · 1 центр
- Outpatient clinics of Aktobe region, West Kazakhstan Marat Ospanov Medical University — Aktobe
Идентификаторы
NCT: NCT07512934 · T3cDM-KZ-Aktobe · 13/2-19-38-GTZh