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Идёт набор NCT04657367

Polish Registry of Diabetes (PolReD)

Наблюдательное Diabetes Obesity PreDiabetes Dysglycemia

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
В протоколе указаны: Observational study - registry.
Кому может быть актуально
Состояния в реестре: Diabetes, Obesity, PreDiabetes, Dysglycemia. Базовые параметры: Без ограничений · 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
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)

Обзор

The aim of this project is to create a registry of diabetic patients, containing a detailed clinical profile of each patient, along with omics data, which will be analyzed using artificial intelligence algorithms, and their results will be implemented in the form of new recommendations of care for high-risk patients and those already suffering from diabetes. The study will be conducted prospectively. The project participants will be patients with diabetes, patients at high risk of developing diabetes and a control group of normoglycemic patients who will participate in study visits at the Clinical Research Center of the Medical University of Bialystok.

Подробное описание

The aim of this project is to create a registry of patients at risk of developing diabetes or already diagnosed with diabetes, containing a detailed clinical profile of each patient, along with omics data, which will be analyzed using artificial intelligence algorithms, and their results will be implemented in the form of new recommendations of care for high-risk patients and those already suffering from diabetes.

The study will be conducted prospectively. The project participants will be patients with diabetes, patients at high risk of developing diabetes and a control group of normoglycemic patients who will participate in study visits at the Clinical Research Center of the Medical University of Bialystok.

As part of the project, each patient will participate in one visit at the research center. During the visit, each patient will undergo a detailed medical interview regarding the current health condition, the course of previously diagnosed diseases, family history, physical activity and diet. In addition, venous blood will be taken for each patient, from which the basic metabolic parameters will be determined (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count with smear, presence of antibodies against beta-cell antigens, TSH, ACTH) and omics analyzes will be performed (including genotyping and sequencing of DNA, transcriptomics, metabolomics, proteomics and lipidomics). Additionally, from each patient, saliva, urine, stool sample, and skin and nasal swabs to assess the microbiome will be collected. Each patient will also receive a detailed body composition analysis using bioimpedance and densitometry (DXA) and grip strength analysis. Non-diabetic patients will also undergo an oral glucose load test (OGTT).

In addition, patients who give additional consent will be able to participate in additional visits, including abdominal MR imaging with the assessment of liver steatosis, a biopsy of the vastus lateralis muscle, cardio-pulmonary exercise test, metabolic clamp (euglycemic - hyperinsulinemic) and glycemia assessment using the continuous glucose monitoring system ( CGM).

As part of the project, we plan for follow-up each participant with re-visits in the study centre every five years, covering exactly the same schedule of visits as the patient will make the first time.

Вмешательства

  • Другое Observational study - registry
    Observational study - registry

Первичные конечные точки

  • HbA1c [Срок оценки: every 5 years]
  • Fasting glucose [Срок оценки: every 5 years]
  • 2-hour glucose [Срок оценки: every 5 years]
  • Fasting insulin [Срок оценки: every 5 years]
  • Lean body mass [Срок оценки: every 5 years]
  • Fat mass [Срок оценки: every 5 years]
  • Visceral Adipose Tissue mass [Срок оценки: every 5 years]
  • Weight [Срок оценки: every 5 years]
  • Homeostatic model assessment for insulin resistance (HOMA-IR) [Срок оценки: every 5 years]
  • Homeostatic model assessment of beta cell function (HOMA-beta) [Срок оценки: every 5 years]

Критерии участия

Критерии включения

  • patients with diagnosed diabetes (according to the American Diabetes Association criteria) - diabetes group
  • patients with diagnosed prediabetes (IFG and/or IGT) - prediabetes group
  • patients with normoglycemia (NFG and NGT) - normoglycemia group
  • informed consent

Критерии исключения

  • drug addiction
  • severe psychiatric disorders
  • patients with gestational diabetes mellitus
  • patients unable to give informed consent, legally incompetent or incapable to comply with the study terms and conditions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Польша · 1 центр
  • Clinical Research Centre, Medical University of Bialystok — Bialystok

Идентификаторы

NCT: NCT04657367 · R-I- 002/436/2019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗