Diabetes Type 2 | Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy
Diabetes Type 2 research study
What is the primary objective of this study?
The purpose of this study is to determine whether the combination with ramipril and clopidogrel leads to further improvement of endothelial function, reduction of oxidative stress and reduction of vascular inflammation, compared with ramipril monotherapy, in patients with Diabetes Mellitus type 2 and diabetic nephropathy.
Who is eligible to participate?
Inclusion Criteria: type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria and - HbA1c(glycosylated haemoglobin A1c <7% - Blood pressure ≤130/80 mmHg - LDL (Low Density Lipoproteins) <100 mg/dl - Informed consent Exclusion Criteria: - patients with diabetic nephropathy and estimated GFR <30ml/min with Modification of Diet in Renal Disease equation (MDRD equation) - baseline potassium > 5.2 meq/L - patients with nephrotic proteinuria defined as albumine to creatinine ratio (ACR)> 3.5 g/g or as proteinuria >3.5 g per 1.73 m2 per 24 hours - history or evidence of non-diabetic kidney disease - history of stroke, peripheral artery disease, coronary artery disease - history or evidence of a secondary form of hypertension - history of severe hepatic failure, malignancy, severe endocrinopathy,autoimmune disease or chronic inflammatory disease - any known bleeding or platelet disorder or platelets <100.000/μL - heart failure in New York Heart Association(NYHA) functional class II-IV - inability or unwillingness on the part of the patient to sign the Patient Consent Form - known hypersensitivity to ramipril or to clopidogrel - Women of child-bearing potential - use of oral anticoagulants or other antithrombotic treatment - use of glitazones - patients receiving statins should be on a stable dose of at least 3 months prior to study initiation and dose should be constant during the study - any surgical or medical condition which in the opinion of the investigator may expose the patient to a higher risk in participation in the study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Diabetes Type 2
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RamiprilPatients will receive 10 mg ramipril throughout the study. Each dose will be taken orally once daily. The duration of treatment with ramipril is 26 weeks
Drug:Clopidogrel12 weeks treatment with ramipril 10 mg and clopidogrel 75 mg once daily followed by a 2 week wash out period for clopidogrel and subsequently additional 12 weeks treatment wit both drugs after cross over.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ramiprilRamipril 10 mg tablets. Each dose will be taken orally with water once daily.
clopidogrel and ramiprilclopidogrel 75mg tablet and ramipril 10mg. Each drug will be taken orally with water once daily
Start Date: July 2012
Completed Date: July 2015
Phase: Phase 4
Primary Outcome: Changes in Asymmetric dimethylarginine (ADMA) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy
Secondary Outcome: Changes in ADMA blood levels after treatment with ramipril
Study sponsors, principal investigator, and references
Principal Investigator: Fotios S Iliadis, Lecturer of Internal Medicine
Lead Sponsor: AHEPA University Hospital
Collaborator: Aristotle University Of Thessaloniki