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Идёт набор NCT05974904

Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study

— Наблюдательное Metabolic Dysfunction-associated Fatty Liver Disease Hepatic Steatosis Liver Fibrosis

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: high-sensitivity C-reactive protein to albumin ratio.
Кому может быть актуально
Состояния в реестре: Metabolic Dysfunction-associated Fatty Liver Disease, Hepatic Steatosis, Liver Fibrosis. Базовые параметры: 18 лет — 90 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

Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study

Обзор

The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD). The main question\[s\] it aims to answer are: \[question 1\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \[question 2\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?

Подробное описание

Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).

Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.

Вмешательства

  • Другое high-sensitivity C-reactive protein to albumin ratio
    High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.

Первичные конечные точки

  • Controlled attenuation parameter [Срок оценки: at baseline]
Вторичные конечные точки (1)
  • Liver stiffness measurement [Срок оценки: at baseline]

Критерии участия

Критерии включения

  • Total participants from NHANES 2017-2020
  • Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.
  • Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).
  • Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
  • If presence of at least two metabolic risk abnormalities:
  • Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)
  • Blood pressure≥130/85 mmHg or specific drug treatment
  • Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment
  • Plasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment
  • Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \[5.6 to 6.9 mmol/L\], or 2-hour post-load glucose levels 140 to 199 mg/dl \[7.8 to 11.0 mmol\] or HbA1c 5.7% to 6.4% \[39 to 47 mmol/mol\])
  • Homeostasis model assessment of insulin resistance score≥2.5
  • Plasma high-sensitivity C-reactive protein level >2 mg/L

Критерии исключения

  • Liver ultrasound data not available
  • participants without complete clinical data
  • participants under 18 years old
  • participants with cancer.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital of Chongqing Medical University — Чунцин

Публикации

  • Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for m PMID 32278004
  • Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Ja PMID 30689971
  • Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021. PMID 34745112

Идентификаторы

NCT: NCT05974904 · ChongqingMUU

Первоисточники (государственные реестры)

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