PIRAMIDE: Network-based Approach in Type 2 Diabetes and Its Cardiovascular Risk

Sponsor

Giuditta Benincasa (Other)

Overall Status

Unknown status

CT.gov ID

NCT03792607

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Cardiovascular Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Perturbation of Interactome Through Micro-RNA And Methylome Analyses In Diabetes Endophenotypes: the PIRAMIDE Study Design

Actual Study Start Date :

Feb 14, 2019

Anticipated Primary Completion Date :

Jan 14, 2020

Anticipated Study Completion Date :

Jun 14, 2020

Outcome Measures

Primary Outcome Measures

DNA methylation status both of CD4+ and CD8+ cells [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 [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 [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 .

Secondary Outcome Measures

ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients [12 Months]
The ROC curves will be used to correlation putative epigenetics interactions (DNA methylation and microRNA) with the presence or absence of T2D-related cardiovascular dysfunction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Exclusion Criteria:

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.