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

September 17, 2019 updated by: Giuditta Benincasa

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Recruiting
        • Universita della Campania Luigi Vanvitelli
        • Contact:
          • Giuditta Benincasa, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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".

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA methylation status both of CD4+ and CD8+ cells
Time Frame: 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.
3 Months
Bioinformatics analysis to predict putative novel T2D candidate genes
Time Frame: 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.
6 Months
RNA sequencing analysis both in CD4+ and CD8+ cells
Time Frame: 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 .
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients
Time Frame: 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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giuditta Benincasa

Investigators

  • Principal Investigator: Giuditta Benincasa, MSc, Clinical Department of Internal Medicine and Specialistics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2019

Primary Completion (Anticipated)

January 14, 2020

Study Completion (Anticipated)

June 14, 2020

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRC-2015-2360454

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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