Morbidity in Newly Diagnosed type2 Diabetes in Adults
Condition: Type2 Diabetes Mellitus; Complications
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      -  It is a prospective,observational, cohort study

        -  The main purpose of the study is to assess the prevalence of diabetic chronic
           complications in newly diagnosed type 2 diabetics in suburban area of Algiers.

        -  The secondary purpose is to study the impact of diabetic renal complications as a risk
           factor on the atherothrombotic events.
    

Detailed description: 
      To reach the two purposes, we need to conduct a cohort study:

        -  The cohort population is type 2 diabetes patients that have been recruited in a
           consecutive and exhaustive way. The first consultation is performed in hospital or in
           one of 12 primary care units of Ain-Taya's health sector in Est suburb of Algiers . When
           a glycemia is found at 1.26 g/litre or over, the patient is referred to principal
           investigator to confirm the diagnosis of type 2 diabetes ,to recruit him and proceed to
           complete screening for chronic complications

        -  For the main purpose, we evaluate the prevalence of micro and macrovascular
           complications, at the time of diagnosis, in type2 diabetes patients that have been
           recruited. For some complications as Diabetic Kidney Disease, we have to follow up the
           patient at least three months to confirm the chronic nature of the nephropathy.

        -  For the secondary purpose, the cohort population is followed up for one year, the
           patients are treated commonly. We'll check out all the cardiovascular events linked to
           atherothrombosis.Two groups of patients might be formed:

             -  The first group is composed of all diabetic patients, with chronic Kidney disease
                (CKD) and without atherothrombotic disease. CKD is defined by albuminuria (micro or
                macroalbuminuria) and/or renal failure, present for more than 3 months . All the
                patients with CKD are considered to be "exposed" to atherothrombotic disease.

             -  The second group is composed of all diabetic patients, without CKD and without
                atherothrombotic disease. This group is considered to be "not exposed" to the
                atherothrombotic disease.

      We will compare the two groups, on occurence of cardiovascular events, after adjustment of
      age and major cardiovascular risk factors, and after excluding patients 'not exposed' having
      had a prior treatment with conversion enzyme inhibitor or angiotensin receptor antagonist .

        -  The size of the sample is calculated with statistical formula:

           n= E2 Po Qo / i2 n= size of the sample E= 1.96 with error risk : alpha= 5% Po= 30% Qo=
           1-Po "n" is at least egal to 323 patients

        -  Statistical analysis is performed with epi info 6.04b and all tests are performed with
           an error risk alpha= 5%

             -  Descriptive statistics of patients characteristics:

                  -  For quantitative variables,we will calculate means,standard deviations, median
                     and quantiles.

                  -  for qualitative variables, percentage will be calculated.

             -  Comparative statistics according to existence of renal disease or not

                  -  Khi-square test is performed for qualitative variables

                  -  Student test: for two means comparison

                  -  Anova test: to compare more than two means

             -  Multivariate analysis will be done on SPSS v: 21 software program, adjustment will
                be done for age, sexe and major cardiovascular risk factors.
    

Intervention name(s): no specific treatment
Intervention type(s): Other
Intervention description(s): lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population of type 2 diabetes patients that diabetes is diagnosed recently, in one of the
        health structures, in the east suburban area of Algiers. In the first step they are
        recruited by primary care physicians, on the basis of glycemia >= 1.26 g/l (capillary or
        venous); then they are automatically directed to the main investigator, in hospital
        consultation, to confirm by two blood samples, the hyperglycemia; and (second step) screen
        for differential diagnosis (secondary diabetes)before the definitive recruitment.Patients
        are systematically,consecutively recruited. They are followed up during 1 year, they are
        seen every 3months at least.
      
Biospecimen description: 
      Blood. Urines. Tissue (kidney) for few patients.
    
Keywords: Type2 diabetes mellitus; Microangiopathy; Chronic Kidney disease; Cardiovascular disease