Prevention of Cardiac and Vascular Events in Patients With NGT/IGT.

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00408577
First received: December 6, 2006
Last updated: December 11, 2006
Last verified: December 2006
  Purpose

Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are associated with increased cardiovascular disease and recent studies suggested the need to detect these glucose abnormalities early in the post-infarction period. Although in the last ten years procedures of coronary revascularisation have dramatically improved the outcome of non diabetic patients affected by ischemic heart disease, these procedures are less effective in patients with type 2 diabetes mellitus and IGT. Possible causes of worse prognosis in these patients could be related to the presence of hyperinsulinemia and insulin resistance due to the well known effect of insulin to increase neointimal tissue proliferation and in-stent restenosis, by stimulating vascular smooth muscle cell growth factors and migration. In addition, it is well known that endothelial dysfunction is an early functional disturbance in the development of atherosclerotic lesions. The impairment of eNOS action might change the turnover rate of eNOS or nitric oxide production and action influencing nitric oxide signalling, apoptosis cascade and angiogenesis. All these factors can contribute to endothelial dysfunction to a certain extent, and accelerate atherosclerosis with increased risk for cardiovascular disease.

The constitutively expressed eNOS, is likely to be the major contributors to whole-body nitric oxide production. It is interesting to note that a region of chromosome 7q seems to influence both insulin resistance and blood pressure, suggesting that this locus may broadly influence traits associated with insulin resistance.

L-arginine is an essential amino acid and its availability is important for the normal endothelial cell function and its intracellular reduction may contribute to the dysfunctional endothelial state. It is well known that L-arginine is as a precursor for nitric oxide and both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular dilation under certain conditions.

Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic, endothelial variables and on myocardial function in patients with cardiovascular disease.


Condition Intervention Phase
Cardiovascular Disease
Drug: L-arginine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Cardiovascular Relapses by L-Arginine Oral Administration in Patients With CAD and IGT and/or Insulin Resistance.

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Evaluation of 6 months L-arginine/placebo oral treatment on glucose tolerance and insulin resistance measured by OGTT

Secondary Outcome Measures:
  • Evaluation of 6 months L-arginine/placebo oral treatment on endothelial function

Estimated Enrollment: 150
Study Start Date: November 2004
Estimated Study Completion Date: November 2006
Detailed Description:

Condition: Patients submitted to coronary revascularization characterized for glucose tolerance after OGTT Intervention: L-arginine for 6 months Inclusion criteria: patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation). Age > 30 years, male and female. Fasting glucose levels below 126 mg/dl.

Exclusion criteria. Type 1 diabetes mellitus, known type 2 diabetes mellitus, pregnancy, impaired kidney and liver function, severe and not treated arterial hypertension.

Study type: randomized, double blind, Placebo, parallel

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation).
  • Age > 30 years, male and female.
  • Fasting glucose levels below 126 mg/dl.

Exclusion Criteria:

  • Type 1 diabetes mellitus,
  • known type 2 diabetes mellitus,
  • pregnancy,
  • impaired kidney and liver function,
  • severe and not treated arterial hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408577

Locations
Italy
Scientific Institute San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: PierMarco Piatti, MD Scientific Institute San Raffaele
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00408577     History of Changes
Other Study ID Numbers: OSRAFFA_III_2004_003
Study First Received: December 6, 2006
Last Updated: December 11, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
glucose intolerance
cardiovascular disease
insulin resistance
endothelial dysfunction

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014