Cardiovascular Risk Factors in Patients With Diabetes -a Prospective Study in Primary Care
Condition: Diabetes Mellitus Type 2; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to prospectively explore the impact from the different
      cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients
      with type 2 diabetes.
    

Detailed description: 
      CARDIPP (Cardiovascular Risk factors in Patients with Diabetes - a Prospective study in
      Primary care) was launched in 2005 with the aim of identifying markers for cardiovascular
      disease to facilitate earlier and individually adjusted intervention in middle aged patients
      with type 2 diabetes. The patients in CARDIPP were consecutively recruited from primary
      health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005
      through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years
      and the participation in the study was performed as an extended annual follow up. Blood
      pressure was measured as the average of three seated measurements taken 1 minute apart and
      standard anthropometric and clinic evaluations were performed including measurement of waist
      circumference and sagittal abdominal diameter which is a new and promising measurement of
      abdominal obesity that may serve as a surrogate marker of insulin sensitivity. We also
      obtained a recording of 24-hour ambulatory blood pressure. The patients filled out a detailed
      questionnaire for evaluation of life style factors and exercise habits. Pedometer-determined
      ambulatory activity for three consecutive days in combination with the questionnaires was
      used for quantification of daily physical activity.

      The cardiovascular investigations were performed at the Department of Physiology, Linköping
      University Hospital and at County Hospital Ryhov, Jönköping, Sweden. The patients were
      subjected to cardiac ultrasonography for calculation of left ventricular mass and ejection
      fraction as well as diastolic cardiac function. Measurement of the carotid, femoral and
      radial pulse pressure wave form is performed by aid of tonometry, with pressure wave analysis
      and calculation of central blood pressure. Furthermore, pulse wave velocity in both central
      elastic and muscular peripheral arteries is defined as an index of arterial wall stiffness.
      The intima-media thickness (IMT) and the lumen diameter (LD) of the carotid arteries were
      evaluated using a B-mode ultrasound.

      CARDIPP-R comprises a re-investigation of the cohort four years after the completion of the
      baseline examination and will thus start in November 2009 and will be completed by 2012. In
      CARDIPP-R, all participants from the baseline study will be invited to the re-investigation.
      The CARDIPP-R study protocol for the cardiac ultrasonography, the carotid ultrasonographic
      investigations and tonometry for measurements of the carotid, femoral and radial pulse
      pressure wave form and pulse wave velocity will follow the CARDIPP baseline protocol.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients in CARDIPP were consecutively recruited from primary health care centres in
        the counties of Östergötland and Jönköping, Sweden from November 2005 through December
        2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the
        participation in the study was performed as an extended annual follow up.
      
Biospecimen description: 
      Blood samples were drawn in the fasting state and analysed for levels of HbA1c, hs-CRP,
      cytokines, lipid and lipoprotein status etc. RNA is extracted from whole blood and the
      PPAR-gamma isoform was determined after RT-PCR and analysis of DNA sequence. Several small
      vials of plasma and serum are stored for later analysis of different hormones, cytokines and
      antibodies (when the economy of the project allows this, high priority is antibodies against
      GAD and islet beta-cells and levels of hormones such as resistin, adiponectin, leptin and
      markers of inflammation in terms of cytokines as IL-1, IL-6, IL-10). Other genetic
      polymorphisms of importance for risk assessment will also be analysed when the economy allows
      this.