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

Cardiovascular Diseases Clinical Trial

— PIRAMIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792607
• Other study ID #: RRC-2015-2360454
• Status: Recruiting
• Start date: February 14, 2019
• Est. completion date: June 14, 2020

Study information

• Verified date: September 2019
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Giuditta Benincasa, MSc
• Phone: +390815667916
• Email: giuditta.benincasa[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Exclusion Criteria:

• Patients with known history of cancer, malignancy disorders, active infections, and chronic or immune-mediated diseases.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Italy	Università della Campania Luigi Vanvitelli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Giuditta Benincasa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation status both of CD4+ and CD8+ cells	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.	3 Months
Primary	Bioinformatics analysis to predict putative novel T2D candidate genes	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.	6 Months
Primary	RNA sequencing analysis both in CD4+ and CD8+ cells	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 .	3 Months
Secondary	ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients	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.	12 Months