NCT01250340

Brief Summary

In individuals with Type 2 Diabetes (T2D) it has been obtained an outstanding improvement in the management of hyperglycemia, but it has not been achieved a similar result in the reduction of the atherosclerotic syndrome. The comprehension of the mechanisms that link over nutrition to inflammation and innate immune response can be important to understand the relationship between insulin resistance, diabetes mellitus and endothelial dysfunction. It will be investigated: 1) the role of Toll Like Receptors (TLR)s in the pathophysiology of T2D and associated atherosclerosis; 2) the role of aspirin and nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibitor/s in the production of TxA2 and F2-isoprostanes in T2D patients; 3)new biomarkers associated to Diabetes and atherosclerosis including markers of endothelial dysfunction and cytokines. It will be analyzed in isolated platelets from normal controls and/or diabetic patients the production of TxA2, isoprostanes and pro-inflammatory/thrombotic cytokines using aspirin and NADPHoxidase inhibitors.

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
80

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2010

Typical duration for phase_4 type-2-diabetes-mellitus

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

August 30, 2010

Last Update Submit

November 27, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesIsoprostanesThromboxaneAspirin

Outcome Measures

Primary Outcomes (1)

  • Changes of isoprostanes after study drug administration.

    Mearuring levels of isoprostanes to understand if isoprostanes could play a crucial role in thrombus formation, independently from Aspirin mediated COX-1 inhibition, supporting their role in the phenomenon of the so call "aspirin resistance" in the setting of T2DM.

    3 and 30 days

Study Arms (2)

Aspirin

EXPERIMENTAL

100 mg/day for 30 days

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

1 cp /day for 30 days

Drug: Placebo

Interventions

AspirinDRUG

100 mg/day for 30 days

Aspirin
PlaceboDRUG

1 cp day for 30 days

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus (defined according to the criteria of the American Diabetes Association)
  • Sign of a written informed consent to participate to the interventional study

You may not qualify if:

  • Liver disease
  • Serious renal disorders (serum creatinine \>2.5 mg/dL)
  • History or evidence of previous major vascular events (myocardial infarction, transient ischemic attack, stroke)
  • History of major bleeding
  • Autoimmune diseases
  • Cancer or present or recent infections
  • Use of non-steroidal anti-inflammatory drugs, drugs interfering with cholesterol metabolism, or vitamin supplements or antiplatelet drugs in the previous 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza Università di Roma

Rome, Italy, 00161, Italy

RECRUITING

Related Publications (2)

  • Carnevale R, Iuliano L, Nocella C, Bartimoccia S, Trape S, Russo R, Gentile MC, Cangemi R, Loffredo L, Pignatelli P, Violi F; IPINET group. Relationship between platelet and urinary 8-Iso-PGF2alpha levels in subjects with different degrees of NOX2 regulation. J Am Heart Assoc. 2013 Jun 14;2(3):e000198. doi: 10.1161/JAHA.113.000198.

    PMID: 23770972DERIVED

  • Cangemi R, Pignatelli P, Carnevale R, Nigro C, Proietti M, Angelico F, Lauro D, Basili S, Violi F. Platelet isoprostane overproduction in diabetic patients treated with aspirin. Diabetes. 2012 Jun;61(6):1626-32. doi: 10.2337/db11-1243. Epub 2012 Mar 16.

    PMID: 22427378DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Francesco Violi

    Divisione di Prima Clinica Medica - Sapienza University of Rome

    STUDY CHAIR

Central Study Contacts

Francesco Violi, Full Prof

CONTACT

+39-06-4461933francesco.violi@uniroma1.it

Stefania Basili, Ass Prof

CONTACT

+39-06-49974678stefania.basili@uniroma1.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor of internal medicine

Study Record Dates

First Submitted

August 30, 2010

First Posted

November 30, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

December 1, 2012

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

IT(1)