(Type 2 Diabetes) (MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease) (Liver Fibrosis) (Glycemic Control) (Anthropometric Indices).
Conditions
Interventions
The participants in this study are adult aged 18-65 years with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD), who will be followed for 6 months. These individua
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals aged 18 to 65 years with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD) Willingness to cooperate
Exclusion criteria
Exclusion criteria: Pregnancy history of psychiatric illness and use of antipsychotics history of viral hepatitis, autoimmune hepatitis liver or kidney transplant history of rheumatologic diseases alcohol consumption history glucocorticoid use history other types of diabetes (such as type 1 diabetes, MODY, etc.) recent surgery within the last three months chronic neurological diseases chronic hepatitis C infection alcoholic liver disease severe and incurable diseases Cushing’s syndrome rheumatoid arthritis use of osteoigenic drugs patients with other types of diabetes cancer breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the FIB-4 index: The extent of change in this index after the intervention (glycemic and anthropometric control) will be the primary evaluation criterion. The aim is to determine whether controlling blood sugar and anthropometric indices can lead to an improvement (reduction) in the FIB-4 index. Timepoint: before the intervention starts and 6 months after it begins, in order to assess the impact of glycemic and anthropometric control on the FIB-4 index and other variables.”. Method of measurement: IB-4 Index:Calculation Method: Calculated using the following formula:Age (years) x AST (IU/L) / (PLT (10^9/L) x vALT (IU/L))AST: Aspartate AminotransferaseALT: Alanine AminotransferasePLT: Platelet countUnit of Measurement: Unitless (numerical value)Glycemic Indices:Fasting Blood Glucose (FBG):Measurement Device: Standard laboratory glucometerUnit of Measurement: Milligrams per deciliter (mg/dL)Glycated Hemoglobin (HbA1c):Measurement Method: Immunoassay or High-Performance Liquid Chromatography (HPLC)Unit of Measurement: Percentage (%)Anthropometric Indices:Weight:Scale: Standard digital scaleUnit of Measurement: Kilograms (kg)Height:Stadiometer: Fixed stadiometerUnit of Measurement: Centimeters (cm)Waist Circumference:Measurement Method: Using a measuring tape at the narrowest part of the waist, between the last rib and the pelvic bone.Unit of Measurement: Centimeters (cm)Hip Circumference:Measurement Method: Using a measuring tape at the widest part of the hips.Unit of Measurement: Centimeters (cm)Body Mass Index (BMI):Calculation Method: Weight (kg) divided by height (meters) squaredUnit of Measurement: Kilograms per square meter (kg/m²)Dietary Intake:Questionnaire: 24-hour dietary recall questionnaireEvaluation Method: Analysis of questionnaire data by a nutritionist or using nutritional analysis software. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Habits. Timepoint: t the beginning of the study, before any intervention is implemented and At the end of the intervention period. Method of measurement: 3-Day Food Diary: Participants will be instructed to record all food and beverages consumed over three consecutive days. Detailed instructions on how to record the food intake will be provided. Registered dietitians will provide training to participants on how to properly fill out the diary. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mahsa Malekian
Tabriz University of Medical Sciences
Outcome results
None listed