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

1 sierpnia 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Szczegółowy opis

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).

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

250

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • Sohag Governorate
      • Sohag, Sohag Governorate, Egipt
        • Sohag university hospital
        • Kontakt:
        • Główny śledczy:
          • aliaa khyry shaban, assistant lecturer

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

adults with T1D who attend to Sohag University Hospital

Opis

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

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
frequancy of MASLD in T1D
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: aliaa khyry shaban, assistant lecturer, Faculty of Medicine Sohag University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

22 sierpnia 2026

Zakończenie podstawowe (Szacowany)

22 sierpnia 2027

Ukończenie studiów (Szacowany)

22 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

1 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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