Type 2 Diabetes MellitusPIRAMIDENCT03792607
Network-based Approach in Type 2 Diabetes and Its Cardiovascular Risk
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Giuditta Benincasa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2019to 14 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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".
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Claudio Napoli, Professor contact
Italy1 site, 1 recruiting
- Recruiting
Università della Campania Luigi Vanvitelli
Naples
Giuditta Benincasa, MSc
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Network medicine, Epigenetics, Diabetes, Cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 .
Measured: 3 Months
Secondary outcomes (1)
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start14 Feb 2019
- Primary completion14 Jan 2020 (estimated)
- Study completion14 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giuditta Benincasa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giuditta Benincasa, University of Campania Luigi Vanvitelli
- Investigators
- Giuditta Benincasa, MSc, Principal investigator, Clinical Department of Internal Medicine and Specialistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792607
- Sponsor's protocol ID
- RRC-2015-2360454
- Acronym
- PIRAMIDE
- Status last verified
- Sep 2019
- First submitted
- 21 Dec 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33194177
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perturbation of Interactome Through Micro-RNA And Methylome Analyses In Diabetes Endophenotypes: the PIRAMIDE Study Design
- ClinicalTrials.gov ID
- NCT03792607
- Acronym / sponsor ID
- PIRAMIDE / RRC-2015-2360454
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Network medicine, Epigenetics, Diabetes, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Giuditta BenincasaUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 14 Jan 2020 (estimated)
- Study completion
- 14 Jun 2020 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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".
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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 .
1 secondary outcome
ROC curves to evaluate putative DNA methylation/microRNA interactions as prognostic biomarkers of cardiovascular dysfunction in T2D patients
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 33194177Benincasa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Napoli, Professor contact
Giuditta Benincasa, MSc principal investigator
Clinical Department of Internal Medicine and Specialistics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Cardiovascular Diseases, run by Giuditta Benincasa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuditta Benincasa, MSc (+390815667916, giuditta.benincasa@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA methylation status both of CD4+ and CD8+ cells (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.