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NCT07750210Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
1 Aug 2026
Start date
22 Aug 2026
Primary completion date
22 Aug 2027
Lead sponsor
Sohag University
NCT number
NCT07750210

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 22 Aug 2026 to the primary completion date, 22 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (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

Other

  • \-

Who the study is looking for

  • age ≥ 18years,
  • diagnosis of T1DM

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sohag University Hospital
Coordinator of this site? Confirm its status
SohagEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.