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Type 2 Diabetes Mellitus and Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250340
Recruitment Status : Unknown
Verified November 2012 by Francesco Violi, University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : November 30, 2010
Last Update Posted : November 28, 2012
University of Rome Tor Vergata
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE August 30, 2010
First Posted Date  ICMJE November 30, 2010
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2010)
Changes of isoprostanes after study drug administration. [ Time Frame: 3 and 30 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01250340 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Type 2 Diabetes Mellitus and Atherosclerosis
Official Title  ICMJE Type 2 Diabetes Mellitus: Role of Inflammation and Innate Immunity in The Pathogenesis of Endothelial Dysfunction and Atherosclerosis
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.

Detailed Description

Study design: prospective, controlled, randomized study. All eligible patients will be randomly assigned in a 1:1 manner to receive aspirin or placebo.

In each recruited subjects we will do:

  1. Anamnestic clinical information and Anthropometric measurements
  2. Electrocardiogram, echocardiogram and ultrasound assessment of carotid intima-media thickness (IMT) and flow-mediated dilatation (FMD)
  3. Ankle-Brachial Index measurement (ABI)
  4. blood samples from an antecubital vein after an overnight fast and urine samples at baseline, after 3 days and after 30 days of aspirin (100 mg/day) administration.

Laboratory Methods: Blood samples will be immediately centrifuged at 2,000 rpm for 20 min at 4°C, and the supernatant was collected and stored at -80°C until measurement. All measurements will be done blinded. Samples will be tested in duplicate, and those showing values above the standard curve will be re-tested with appropriate dilutions.Analysis of urinary and platelet isoprostane:Urinary PGF2α-III was measured by a previously described and validated EIA assay method. Ten millilitre urine were extracted on a C-18 SPE column; the purification was tested for recovery by adding a radioactive tracer (tritiated PGF2α-III) (Cayman chemical). The eluates were dried under nitrogen, recovered with 1ml of buffer, and assayed in a PGF2α-III specific EIA kit (Cayman chemical). Urinary PGF2α-III concentration was corrected for recovery and creatinine excretion and expressed as pg/mg of creatinine. PRP was then centrifuged 20 min at 800 g to concentrate platelets and the pellet was suspended in Tyrode buffer to obtain a final platelet concentration of 5x108/mL. PGF2α-III content was measured by a validated EIA assay method as previously described and expressed as pg/mg platelet protein.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Aspirin
    100 mg/day for 30 days
  • Drug: Placebo
    1 cp day for 30 days
Study Arms  ICMJE
  • Experimental: Aspirin
    100 mg/day for 30 days
    Intervention: Drug: Aspirin
  • Placebo Comparator: Placebo
    1 cp /day for 30 days
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01250340
Other Study ID Numbers  ICMJE Diabetes and Oxidative Stress
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Violi, University of Roma La Sapienza
Study Sponsor  ICMJE University of Roma La Sapienza
Collaborators  ICMJE University of Rome Tor Vergata
Investigators  ICMJE
Study Chair: Francesco Violi Divisione di Prima Clinica Medica - Sapienza University of Rome
PRS Account University of Roma La Sapienza
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP