Clinical Trial

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

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Summary
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
Trial Details
NCT Number NCT07750210
Lead Sponsor Sohag University
Conditions MASLD, Type 1 Diabetes
Enrollment 250 participants
Start Date 2026-08-22
Primary Completion 2027-08-22 (estimated)
Study Completion 2028-08-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-06