- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07750210
Study of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults With Type 1 Diabetes
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
- Type 2 diabetes mellitus
- using glucocorticoids
- long-term alcohol consumption
- 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 :
- Complete history taking for Age, Sex, comorbidities (hypothyroidism, arterial hypertension, and dyslipidemia), duration of diabetes, insulin dose,.
A thorough clinical examination will stress on:
-BMI calculated as the ( weight (kg)/height (m)(8).
- waist circumference
- The following investigations will be done to every subject:
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).
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: aliaa khyry shaban, assistant lecturer
- Telefonnummer: 01067655291
- E-mail: aliaakhairy@med.sohag.edu.eg
Studiesteder
-
-
Sohag Governorate
-
Sohag, Sohag Governorate, Egypten
- Sohag university hospital
-
Kontakt:
- aliaa khyry shaban, M.B.B.CH. MSC
- Telefonnummer: 01067655291
- E-mail: aliaakhairy@med.sohag.eg
-
Ledende efterforsker:
- aliaa khyry shaban, assistant lecturer
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age ≥ 18years,
- 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
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
adults with type 1 diabetes
Patients Inclusion criteria: (1) age ≥ 18years, (2) diagnosis of T1DM Exclusion Criteria.
Methods: All groups will be subjected to :
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
frequancy of MASLD in T1D
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: aliaa khyry shaban, assistant lecturer, Faculty of Medicine Sohag University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Soh-Med--26-7-3MD
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .