Morbidity in Newly Diagnosed type2 Diabetes in Adults — MORNDIAB  

Type2 Diabetes Mellitus Clinical Trial

Official title: Prevalence of Micro and Macroangiopathy in Newly Diagnosed type2 Diabetic Adults in Suburban Area of Algiers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

• NCT number: NCT02002091
• Study type: Observational
• Source: University of Algiers
• Status: Completed
• Start date: January 2009
• Completion date: December 2014