Perturbation of Interactome Through Micro-RNA And Methylome Analyses In Diabetes Endophenotypes: the PIRAMIDE Study Design
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- DNA methylation status both of CD4+ and CD8+ cells
研究概览
简要总结
PIRAMIDE study design will test the hypothesis that simultaneous interactions between DNA methylation and microRNAs may hit T2D candidate genes and predict the development of T2D-related cardiovascular complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Clinical Diagnosis of Type 2 Diabetes. In according to current guidelines, diabetes is diagnosed by evidence of impairing fast glucose (IFG) > 7.0 mmol/L (>125 mg/dl), post prandial glycemia > 11.1 mmol/L (>200 mg/dl), and evidence of glycated hemoglobin (HbA1c) > 6.6%. Clinical and demographic characteristics of study population will be avaiable from datasets generated by physicians.
- •Clinical Diagnosis of macrovascular dysfunction.
- •Exclusion Criteria:
- •Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.
结局指标
主要结局
DNA methylation status both of CD4+ and CD8+ cells
时间窗: 3 Months
Using Methylation 27K BeadChip platform based on Bisulfite conversion technology, DNA methylation profile of 35 preselected T2D patients will be measured both in CD4+ and CD8+ cells collected from peripheral blood respect with controls.
Bioinformatics analysis to predict putative novel T2D candidate genes
时间窗: 6 Months
The network-based algorithm "Weighted Human DNA methylation PPI network (WMPN)" will be applied to methylome data in order to obtain a disease module containing the crucial differentially methylated genes both in CD4+ and CD8+ cells from T2D patients and controls.
RNA sequencing analysis both in CD4+ and CD8+ cells
时间窗: 3 Months
RNA sequencing analysis by using Illumina HiSeq2000 Next Generatin Sequencing (NGS) platform will be performed for identifying differentially expressed micro-RNA and mRNA target both in CD4+ and CD8+ cells isolated from T2D patients and controls .
次要结局
- ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients(12 Months)
研究者
Giuditta Benincasa
Principal Investigator GIUDITTA BENINCASA
University of Campania "Luigi Vanvitelli"