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Study of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults With Type 1 Diabetes

2026년 8월 1일 업데이트: Aliaa Khairy Shabaan, Sohag University

Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.

Recent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (> F2) is observed 'in 13.2% and advanced fibrosis (> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.

Recent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (> F2) is observed 'in 13.2% and advanced fibrosis (> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.

Recent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (> F2) is observed 'in 13.2% and advanced fibrosis (> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.

Recent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (> F2) is observed 'in 13.2% and advanced fibrosis (> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways

연구 개요

상태

아직 모집하지 않음

상세 설명

Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.

Recent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (> F2) is observed 'in 13.2% and advanced fibrosis (> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways (3,4).

Due to the association of MASLD and adverse clinical outcomes, international guidelines recommend screening individuals with metabolic risk factors through the use of clinical tools and noninvasive indices (aspartate aminotransferase (AST)/alanine transaminase (ALT) levels, Fibrosis-4 index (FIB-4), hepatic steatosis index (HSI), and fatty liver index (FLI)) and imaging (5).

The combined use of scales and imaging studies offers an accessible and low-cost method for identifying patients at risk of liver fibrosis, facilitating early preventive and therapeutic interventions (5,6) Most non-invasive indices currently used to stratify MASLD ,and liver fibrosis risk were developed and validated in T2D or with metabolic diseases. However, their diagnostic performance in T1D remains uncertain as they may behave differently in the patients with T1D. (7).

Aim of the work:

The aim of the work is to study the frequancy of MASLD in T1D and to characterize non-invasive markers of MASLD and liver fibrosis risk in adults with T1D who attend to Sohag University Hospital

Patients and Methods:

This is a cross-sectional, observational study Sample size sample size is 250 patients calculated using Cochran Formula n=z^2*p(1-p)/d^2 For prevalence 25%,confidance level 95% and power80% Patients

Inclusion criteria:

(1) age ≥ 18years, (2) diagnosis of T1DM Exclusion Criteria.

  1. Type 2 diabetes mellitus
  2. using glucocorticoids
  3. long-term alcohol consumption
  4. previous diagnosis of other chronic liver diseases (viral, autoimmune, etc.), major diseases such as liver cirrhosis or tumors

Methods:

All groups will be subjected to :

  1. Complete history taking for Age, Sex, comorbidities (hypothyroidism, arterial hypertension, and dyslipidemia), duration of diabetes, insulin dose,.
  2. A thorough clinical examination will stress on:

    -BMI calculated as the ( weight (kg)/height (m)(8).

    • waist circumference
  3. The following investigations will be done to every subject:
  1. Glycated hemoglobin (HbA1c), 2- Lipid profile 3- AST, ALT(IU/L) 4- CBC 5- abdominal ultrasound 6- gamma-glutamyl transferase (GGT)and 7-fibroscane(Fibroscan 430, By Echosens company, france)for MASLD patients

    T1D is diagnosed according to ADA diagnostic criteria of T1D (12) MASLD is characterized by hepatic steatosis (fatty liver) in individuals with at least 1 cardiometabolic risk factor(13), and is characterized by specific manifestations in imaging.

    Cardiometabolic risk factors significant to meet diagnostic criteria include at least 1 of these 5 factors:

    -BMI > 25 kg/m2 (BMI > 23 in Asian populations) or waist circumference > 94 cm (men) or 80 cm (women)

    -Fasting serum glucose > 100 mg/dL or HgbA1c > 5.7% or type 2 diabetes or current treatment for type 2 diabetes

    • Blood Pressure > 130/85 mm/Hg or currently being treated with antihypertensives
    • Triglycerides > 150 or currently being treated with lipid lowering therapy
    • HDL cholesterol < 40 mg/dL (men) or HD < 50 mg/dL (women) or currently being treated with lipid-lowering medications.(14)

    Non-invasive indices [Hepatic steatosis index(HSI), fatty liver index (FLI), are used to estimate the risk of MASLD, and Fibrosis-4 score (FIB-4) and fibroscane are used for fibrosis risk stratification.

    • FLI: [0.953 × ln(triglycerides) + 0.139 × BMI + 0.718 × ln(GGT) + 0.053 × waist circumference - 15.745]. Interpretation: <30, low risk; 30-60, intermediate risk; > 60, high risk (9).
    • FIB-4: [(Age × AST)/(Platelets × √ALT)]. Interpretation:

    fibrosis stage 0-1; <1.30 fibrosis stage 2-3; 1.30-2.67 fibrosis stage 4-5: > 2.67 (10).

    • HSI: [8 × ALT/AST + BMI + 2 (if had diabetes) + 2 (if female)]. Interpretation: <30, very low risk; 30-36 intermediate risk; > 36, high risk (11).

연구 유형

관찰

등록 (추정된)

250

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Sohag Governorate
      • Sohag, Sohag Governorate, 이집트
        • Sohag university hospital
        • 연락하다:
        • 수석 연구원:
          • aliaa khyry shaban, assistant lecturer

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

adults with T1D who attend to Sohag University Hospital

설명

Inclusion Criteria:

  1. age ≥ 18years,
  2. diagnosis of T1DM

Exclusion Criteria

(1)Type 2 diabetes mellitus (2) using glucocorticoids (3) long-term alcohol consumption (4) previous diagnosis of other chronic liver diseases (viral, autoimmune, etc.), major diseases such as liver cirrhosis or tumors

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
adults with type 1 diabetes

Patients

Inclusion criteria:

(1) age ≥ 18years, (2) diagnosis of T1DM Exclusion Criteria.

  1. Type 2 diabetes mellitus
  2. using glucocorticoids
  3. long-term alcohol consumption
  4. previous diagnosis of other chronic liver diseases (viral, autoimmune, etc.), major diseases such as liver cirrhosis or tumors

Methods:

All groups will be subjected to :

  1. Complete history taking for Age, Sex, comorbidities (hypothyroidism, arterial hypertension, and dyslipidemia), duration of diabetes, insulin dose,.
  2. A thorough clinical examination will stress on:

    • BMI calculated as the ( weight (kg)/height (m)(8).
    • waist circumference
  3. The following investigations will be done to every subject:

1Glycated hemoglobin (HbA1c), 2- Lipid profile 3- AST, ALT(IU/L) 4- CBC 5- abdominal ultrasound 6- gamma-glutamyl transferase (GGT)and 7-fibroscane(Fibroscan 430, By Echosens company, france)for MASLD patients

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
frequancy of MASLD in T1D
기간: at baseline
study the frequancy of MASLD in T1D and to characterize non-invasive markers of MASLD and liver fibrosis risk in adults with T1D who attend to Sohag University Hospital
at baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: aliaa khyry shaban, assistant lecturer, Faculty of Medicine Sohag University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 22일

기본 완료 (추정된)

2027년 8월 22일

연구 완료 (추정된)

2028년 8월 22일

연구 등록 날짜

최초 제출

2026년 8월 1일

QC 기준을 충족하는 최초 제출

2026년 8월 1일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 1일

마지막으로 확인됨

2026년 8월 1일

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