NCT03297749

Brief Summary

The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 26, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

September 26, 2017

Last Update Submit

October 25, 2017

Conditions

Periodontitis, AdultMetabolic Syndrome

Outcome Measures

Primary Outcomes (5)

  • pulse wave velocity

    baseline

  • oxidative stress

    baseline

  • carotid intima-media thickness

    baseline

  • genetic variants

    baseline

  • left ventricular mass

    baseline

Secondary Outcomes (2)

  • inflammatory markers

    baseline

  • subgingival microbes

    baseline

Interventions

Observational study (no intervention)OTHER

No interventions

Also known as: No interventions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with metabolic syndrome will be recruited from outpatients attending the Internal Medicine Unity at the University of Catania.

You may qualify if:

  • Caucasian ethnicity
  • Age 18- 75
  • Diagnosis of metabolic syndrome
  • Presence of at least 12 teeth

You may not qualify if:

  • Pregnancy
  • Presence of infectious diseases such as hepatitis and HIV
  • Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit
  • Use of systemic antibiotics within three months prior to the baseline visit
  • Antibiotic pre-medication required for the performance of periodontal examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Catania

Catania, Italy

Location

UCL

London, EN54LU, United Kingdom

Location

Related Publications (1)

  • Nibali L, Donos N, Terranova V, Di Pino A, Di Marca S, Ferrara V, Pisano M, Scicali R, Rabuazzo AM, Purrello F, Malatino L. Left ventricular geometry and periodontitis in patients with the metabolic syndrome. Clin Oral Investig. 2019 Jun;23(6):2695-2703. doi: 10.1007/s00784-018-2667-8. Epub 2018 Oct 22.

    PMID: 30350134DERIVED

MeSH Terms

Conditions

Chronic PeriodontitisMetabolic Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

July 1, 2015

Primary Completion

September 30, 2017

Study Completion

December 31, 2020

Last Updated

October 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)GB(1)