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Набор скоро начнётся NCT07706010

Cardiovascular Risk in T2DM With MAFLD: A Cohort Study

— Наблюдательное Type 2 Diabetes (T2DM) Metabolic Dysfunction-Associated Steatotic Liver Disease

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: Type 2 Diabetes (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease. Базовые параметры: от 18 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
Китай
Следующий шаг
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Официальное название

A Cohort Study on Cardiovascular Risk in Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-Associated Fatty Liver Disease

Обзор

This study aims to address the following key scientific question by establishing a large-scale, high-standard clinical cohort: the independent contribution of MASLD and its progression to liver fibrosis on cardiovascular outcomes in patients with T2DM, after excluding the confounding effects of traditional cardiovascular risk factors. Its technical value lies in utilizing prospective follow-up data combined with a multivariable competing risks model to develop and validate a cardiovascular risk prediction and early warning system tailored for Chinese populations with T2DM complicated by MASLD. Clinically, the findings will provide interdisciplinary evidence-based support for endocrinology and cardiology, helping clinicians identify high-risk individuals and prevent cardiovascular events through early intervention targeting hepatic metabolic disorders. This has significant implications for reducing overall mortality among diabetic patients in China and alleviating the public health burden.

Первичные конечные точки

  • Major Adverse Cardiovascular Events (MACE) [Срок оценки: Baseline to 5 years]
Вторичные конечные точки (5)
  • Progression of Liver Fibrosis [Срок оценки: Every 12 months up to 5 years]
  • All-cause Mortality [Срок оценки: Baseline to 5 years]
  • Renal Outcomes [Срок оценки: Time Frame: Baseline to 5 years]
  • Cardiovascular Imaging Progression [Срок оценки: Annually for 5 years]
  • Liver-related Clinical Outcomes [Срок оценки: Baseline to 5 years]

Критерии участия

Критерии включения

  • 1.Age ≥18 years, male or female;

2.Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes (2022 edition), with a confirmed diagnosis for at least 3 months;

3.Meet the diagnostic criteria for metabolic dysfunction-associated steatotic liver disease (MASLD) according to the \*Chinese Guideline for the Diagnosis and Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (2024 edition)\*, with preliminary assessment including liver enzymes (ALT/AST), liver ultrasound, and non-invasive fibrosis markers (FIB-4, LSM), and exclusion of other liver diseases;

4.Willing to participate in this study and provide written informed consent;

5.Able to cooperate with baseline survey and long-term follow-up (i.e., expected to reside in the study area during the follow-up period, without severe cognitive impairment, movement disorders, or other conditions that would interfere with follow-up).

Критерии исключения

  • 1.Concomitant other chronic liver diseases: viral hepatitis (hepatitis B, hepatitis C, etc.), alcoholic liver disease (alcohol intake ≥140 g/week for males, ≥70 g/week for females), autoimmune liver disease, drug-induced liver injury, liver cirrhosis, liver cancer, etc.;

2.Concomitant severe cardiovascular or cerebrovascular disease, end-stage renal disease (CKD stage 5), malignant tumor, severe infection, etc., with an estimated life expectancy <5 years;

3.Current use of medications that may significantly affect liver metabolism or glucose metabolism (other than routine glucose-lowering, lipid-regulating, or hepatoprotective agents) that cannot be adjusted;

4.Pregnant or lactating women, or those planning to become pregnant in the near term;

5.Severe mental illness or cognitive impairment that prevents cooperation with surveys and follow-up;

6.Refusal to sign informed consent, or inability to comply with study procedures.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • MingWei Wang — Hanzhou

Идентификаторы

NCT: NCT07706010 · 2026（E2）-KS-077

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗