Status:
UNKNOWN
Carotid Atherosclerosis In Newly Diagnosed Type 2 Individuals
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Consorci d'Atenció Primària de Salut de l'Eixample
Conditions:
Type II Diabetes Mellitus Without Mention of Complication
Eligibility:
All Genders
40-74 years
Brief Summary
It has been hypothesized, based on recent trials, that only early intervention can reduce cardiovascular morbidity and mortality in individuals with type 2 diabetes (T2DM). This finding may imply that...
Detailed Description
Hypothesis: In a Mediterranean population, the investigators hypothesized that the CIMT and the presence of carotid plaque (CP): 1. Are higher in patients with newly diagnosed T2DM than in a control...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult men and women older than 40 years and less than 75 years.
- Newly Diagnosed T2DM (NEWDM). NEWDM is a subject without previous history of diabetes who has laboratory evidence consistent with diabetes (American Diabetes Association) within the last year.
- Exclusion criteria:
- Previous cardiovascular events such as, but not limited to, myocardial infarction, acute coronary syndrome or chronic stroke, peripheral arterial disease, or revascularization surgery in any territory.
- Congestive heart failure (class III-IV).
- Cancer of any kind (except basal cell or for cervical carcinoma insitu) unless disease free is documented in the past five years.
- Anemia or known coagulopathy.
- Serum creatinine greater than 1.5 mg / dl or MDRD (Modification of Diet in Renal Disease) equation \<50.
- Any organ transplant (except cornea)
- Known HIV-positive, active tuberculosis, malaria, chronic viral hepatitis B or C, cirrhosis of any aetiology.
- Pregnant or gestational idea in the next 2-3 years to inclusion.
- History of alcohol dependence (or abusive consumption) or other drugs in the past five years.
- Psychiatric illness that would entail adherence problems.
- Participation in a clinical trial protocol or investigational drugs.
- Debilitating chronic illness or short life expectancy to prevent adherence or therapeutic intensification is not the goal of managing your diabetes.
- ECG signs of ischemic heart disease.
- Diabetes type 1 or anti-GAD antibody positive.
- Control population will be excluded based on the same criteria.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01898572
Start Date
January 1 2012
End Date
June 1 2015
Last Update
June 25 2014
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain, 08036