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

NCT ID: NCT03792607

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2020-06-14

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.


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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Giuditta Benincasa

OTHER

Sponsor Role lead

Responsible Party

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Giuditta Benincasa

Principal Investigator GIUDITTA BENINCASA

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Giuditta Benincasa, MSc

Role: PRINCIPAL_INVESTIGATOR

Clinical Department of Internal Medicine and Specialistics

Locations

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Università della Campania Luigi Vanvitelli

Naples, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuditta Benincasa, MSc

Role: CONTACT

+390815667916

Claudio Napoli, Professor

Role: CONTACT

Facility Contacts

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Giuditta Benincasa, MSc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33194177 (View on PubMed)

Other Identifiers

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RRC-2015-2360454

Identifier Type: -

Identifier Source: org_study_id

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