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

Sponsor
Sohag University
Study ID
NCT07750210
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

First listed
Aug 6, 2026
Start date
Aug 22, 2026
Status verified
Aug 2026
Primary completion
Aug 22, 2027
Completion
Aug 22, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

frequancy of MASLD in T1D [ Time Frame: at baseline ]

Central Contacts

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