Morbidity in Newly Diagnosed type2 Diabetes in Adults (MORNDIAB)

University of Algiers

Status: Completed

Conditions: Type2 Diabetes Mellitus; Complications

Treatments: Other: no specific treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02002091

UAlgiers FM 401/desm/07

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 327 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged from 40 to 70 years
• Newly diagnosed type 2 diabetes
• Never treated for diabetes

Exclusion criteria

• Gestational diabetes

Trial design

327 participants in 1 patient group

Complications,no specific treatment

Description:

After screening for complications, a non specific multi interventional treatment is applied to patients. After one year of follow up, we will compare two groups: with and without chronic kidney disease, on the advent of cardiovascular events. An adjustment is done for age and major risk factors.

Treatment:

Other: no specific treatment