NCT03792607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2020

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

December 21, 2018

Last Update Submit

September 17, 2019

Conditions

Type 2 Diabetes MellitusCardiovascular Diseases

Keywords

Network medicineEpigeneticsDiabetesCardiovascular risk

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients

    12 Months

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will enroll 35 men and women 50 years or older with diagnosis of T2D and 35 sex and age-matched controls. Population study will be recruited at the Department of Medical, Surgical, Neurological, Metabolic and Geriatric Sciences of University della Campania "Luigi Vanvitelli".

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università della Campania Luigi Vanvitelli

Naples, Italy

RECRUITING

Related Publications (1)

  • Benincasa G, Franzese M, Schiano C, Marfella R, Miceli M, Infante T, Sardu C, Zanfardino M, Affinito O, Mansueto G, Sommese L, Nicoletti GF, Salvatore M, Paolisso G, Napoli C. DNA methylation profiling of CD04+/CD08+ T cells reveals pathogenic mechanisms in increasing hyperglycemia: PIRAMIDE pilot study. Ann Med Surg (Lond). 2020 Oct 20;60:218-226. doi: 10.1016/j.amsu.2020.10.016. eCollection 2020 Dec.

    PMID: 33194177DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood CD4+ T cells and CD8+ T cells

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Giuditta Benincasa, MSc

    Clinical Department of Internal Medicine and Specialistics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuditta Benincasa, MSc

CONTACT

+390815667916giuditta.benincasa@unicampania.it

Claudio Napoli, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator GIUDITTA BENINCASA

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 3, 2019

Study Start

February 14, 2019

Primary Completion

January 14, 2020

Study Completion

June 14, 2020

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

IT(1)