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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03792607
Acronym
PIRAMIDE
Enrollment
35
Registered
2019-01-03
Start date
2019-02-14
Completion date
2020-06-14
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Type 2 Diabetes Mellitus

Keywords

Network medicine, Epigenetics, Diabetes, Cardiovascular risk

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.

Interventions

None listed

Sponsors

Giuditta Benincasa
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
DNA methylation status both of CD4+ and CD8+ cells3 MonthsUsing 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 genes6 MonthsThe 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+ cells3 MonthsRNA 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

MeasureTime frameDescription
ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients12 MonthsThe ROC curves will be used to correlation putative epigenetics interactions (DNA methylation and microRNA) with the presence or absence of T2D-related cardiovascular dysfunction.

Countries

Italy

Contacts

Primary ContactGiuditta Benincasa, MSc
giuditta.benincasa@unicampania.it+390815667916
Backup ContactClaudio Napoli, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026