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

2026年8月1日 更新者: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

調査の概要

状態

まだ募集していません

詳細な説明

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).

研究の種類

観察的

入学 (推定)

250

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Sohag Governorate
      • Sohag、Sohag Governorate、エジプト
        • Sohag university hospital
        • コンタクト:
        • 主任研究者:
          • aliaa khyry shaban, assistant lecturer

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

adults with T1D who attend to Sohag University Hospital

説明

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

-

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
frequancy of MASLD in T1D
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:aliaa khyry shaban, assistant lecturer、Faculty of Medicine Sohag University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月22日

一次修了 (推定)

2027年8月22日

研究の完了 (推定)

2028年8月22日

試験登録日

最初に提出

2026年8月1日

QC基準を満たした最初の提出物

2026年8月1日

最初の投稿 (実際)

2026年8月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月6日

QC基準を満たした最後の更新が送信されました

2026年8月1日

最終確認日

2026年8月1日

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

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いいえ

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