CTRI/2024/10/075663招募中不适用
A Clinical Study to Explore Novel Biomarkers for Predicting Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- To measure the serum levels of Biomarkers in all the 4 groups and to correlate them with NAFLD severity assessed by Fibro Scan.
研究概览
简要总结
This study aims to investigate the intricate molecular mechanisms linking T2DM and NAFLD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with Diabetes defined as HbA1c less or equal to 6.5% or FPG 126mg/dL or taking anti-diabetic medication.
排除标准
- •Individuals with a history of significant alcohol consumption-defined as more than 20 grams of alcohol per day for men and 10 grams per day for women,Individuals with a history of other liver diseases, such as viral hepatitis, autoimmune liver diseases, or liver cirrhosis,Pregnant individuals or those planning to become pregnant during the study period,Participants with severe comorbid conditions that could independently affect glucose metabolism or liver function (e.g., advanced chronic kidney disease, advanced heart failure),Individuals taking medications known to significantly impact glucose metabolism (e.g., corticosteroids) or liver function (e.g., methotrexate),Individuals with TB, any form of malignancies presents or history of HIV- AIDS or any disease that could impair the biomarkers levels,Participants with a history of major psychiatric disorders or cognitive impairment.
- •Individuals currently taking medications that significantly impact glucose metabolism or biomarker levels (e.g., corticosteroids, certain antipsychotics),Individuals with a history of major surgery within the last six months,Individuals with acute infections or inflammatory conditions at the time of recruitment.
结局指标
主要结局
To measure the serum levels of Biomarkers in all the 4 groups and to correlate them with NAFLD severity assessed by Fibro Scan.
时间窗: Single Time point (Baseline)
次要结局
- To apply machine learning techniques to develop & validate predictive models for(NAFLD & T2DM based on serum biomarkers & clinical features, & to compare)
研究者
研究点 (1)
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