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IRCT20250506065618N1 IRCT 2025-07-17 Tabriz University of Medical Sciences The Impact of Optimal Glycemic Control on the FIB-4 Index in Patients with Type 2 Diabetes and Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) The Impact of Optimal Glycemic Control on the FIB-4 Index in Patients with Type 2 Diabetes and Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) 2025-07-22 anticipated 83 Complete https://irct.ir/trial/84103 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 (Type 2 Diabetes) (MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease) (Liver Fibrosis) (Glycemic Control) (Anthropometric Indices). 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 individuals will receive pharmaceutical and dietary interventions to control their glycemic and anthropometric status. In other words, the intervention group is a group of individuals who will undergo a series of interventions (pharmaceutical and dietary) to improve their glycemic and anthropometric status, and the effect of these interventions on the FIB-4 index will be investigated. Hemoglobin A1C less than 7% will be considered as good glycemic control.. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set (IPD): If feasible, the complete dataset related to the participants, after removing identifying information (such as names, contact information, etc.), will be shared. If sharing the entire dataset isn’t possible, a portion of the data, such as information related to the primary outcomes (FIB-4 index, blood glucose levels, anthropometric indices) and demographic variables, will be shared. Study Protocol: The complete study protocol, including objectives, hypotheses, methods, inclusion and exclusion criteria, and data collection methods, will be shared. Statistical Analysis Plan: The complete statistical analysis plan, including the statistical methods used, statistical assumptions, and data analysis plans, will be shared. Informed Consent Form: The informed consent form used in the study will be shared (ensuring the removal of any identifying information). Clinical Study Report: The complete clinical study report, including findings, results, discussion, and conclusions, will be shared. Analytic Codes: The analytic codes used for data analysis (such as SPSS or R code) will be shared. Data Dictionary: The data dictionary, including descriptions of variables, units of measurement, and possible values for each variable, will be shared. When: Initial Data Release (Study Protocol, Statistical Analysis Plan, Informed Consent Form): Timeline: These documents will be prepared for release within 3 months following the completion of the primary data collection phase of the study. Main Data Release (Deidentified IPD, Clinical Study Report, Analytic Codes, Data Dictionary): Timeline: These files will be prepared for release within 6 months following the completion of the initial data analysis and the preparation of the first draft of the study manuscript. Additional Notes: Contingencies: These timelines are contingent upon the successful completion of data collection, data analysis, and the preparation of the initial manuscript. Unexpected delays in any of these stages may affect the release dates. To whom: Academic and Scientific Researchers: This group certainly includes researchers from universities, research institutions, and other scientific centers who need the data to conduct further research and confirm or refute the findings of the original study. Researchers Employed in Industry: Individuals working in pharmaceutical, biotechnology, or other health-related industries can also request data. This helps in the development of new drugs and therapies and improves healthcare. Other Healthcare Professionals: Physicians, nurses, and other healthcare professionals seeking to improve the care of their patients can also benefit from the study’s data and findings. General Public: In some cases, access to data is also provided to the general public, especially if the goal is to increase awareness and public participation in scientific research. Of course, in this case, it must be ensured that the data is published in a de-identified manner to protect the privacy of the participants. Conditions: Purpose of Use: The data and documentation must be used solely for research, educational, or healthcare improvement purposes. Commercial use of the data (such as selling the data to third parties) is not permitted. Type of Analysis: Statistical and epidemiological analyses to answer research questions related to the study are permitted. Attempts to identify the identity of participants or use the data in a way that violates their privacy are prohibited. Publication of Results: The results of data analysis must be published in the form of scientific articles, reports, or presentations. All publications must refer to the original study and the source of the data. No part of the data or results should be published in a way that violates the privacy of the participants. Data Storage and Protection: Data and documentation must be stored securely and in a protected location. Access to the data must be limited to those who have permission to use it. Data should not be transferred to any third party without written permission from the original research team. Mechanisms Governing the Use of Data: Data Transfer Agreement (DTA): Before accessing the data, the applicant must sign a Data Transfer Agreement specifying the terms of use of the data. This agreement must include a commitment to ethical principles, respect for the privacy of participants, and non-commercial use of the data. Ethical Review: In some cases, the applicant may be required to provide ethical approval from their institution’s ethics committee for the use of the data. Monitoring: The original research team may monitor the use of the data to ensure that the terms of use are respected. Requirements for Submitting a Request for Access to Data and Documentation: Applicant Information: First and last name Organizational affiliation (university, research institute, company, etc.) Contact information (email, phone) Job or educational position Summary of educational and research background Purpose of Using the Data: A detailed explanation of why the applicant needs the data and what research questions they want to answer. Description of the data analysis plan and the statistical methods to be used. Commitments: Commitment to respecting ethical principles and protecting the privacy of participants. Commitment to not using the data for commercial purposes. Commitment to refer to the original study and the source of the data in all publications. Commitment not to transfer the data to third parties without written permission from the original research team. Commitment to store and protect the data securely. Where to obtain: Contacting the Original Research Team: This method is usually the best and most direct way to obtain accurate and up-to-date information on how to access the data and documentation. Unfortunately, the proposal does not mention the name or contact information of the individual or individuals responsible for responding to requests. It is recommended to search for the contact information of the authors of the proposal (especially Dr. Mahsa Malekian and Dr. Amin Sadrazar) by searching for articles published by them or through the website of the university or institution where they work. How to obtain: Request for Access: The requester must submit a formal written request to the original research team. The request should include the following: The specific purpose for which the data and documentation are requested (e.g., for meta-analysis, replication of the study). A list of specific required documents or data files. A description of how the requester will maintain data confidentiality and ethical principles. The requester’s contact information (name, address, email, phone number). Comments:
public Dr Mahsa Malekian
Tabriz University of Medical Sciences, Golgasht Street , Azadi Street t Street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5941 dr.malekian@yahoo.com Tabriz University of Medical Sciences scientific Dr Mahsa Malekian
Tabriz University of Medical Sciences, Golgasht Street , Azadi Street t Street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5941 dr.malekian@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Individuals aged 18 to 65 years with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD) Willingness to cooperate 18 years 65 years Both 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 Treatment - Other 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 individuals will receive pharmaceutical and dietary interventions to control their glycemic and anthropometric status. In other words, the intervention group is a group of individuals who will undergo a series of interventions (pharmaceutical and dietary) to improve their glycemic and anthropometric status, and the effect of these interventions on the FIB-4 index will be investigated. Hemoglobin A1C less than 7% will be considered as good glycemic control. 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 √ALT (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. 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. University Research Vice-Chancellor’s Office Approved 2025-03-14 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)