Clinical trial NCT02002091: Morbidity in Newly Diagnosed type2 Diabetes in Adults
Official title: Prevalence of Micro and Macroangiopathy in Newly Diagnosed type2 Diabetic Adults in Suburban Area of Algiers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes Mellitus
Complications
Keywords: Type2 diabetes mellitus
Microangiopathy
Chronic Kidney disease
Cardiovascular disease
Lead sponsor: University of Algiers
Sponsor class: OTHER
Collaborators: name: National Institute of public Health, Algeria
name: Hopital Ain Taya
name: Parnet Hospital
name: Hôpital Mustapha Pacha
name: Birtraria Hospital
name: Bab El Oued Teaching Hospital
First posted: 2013-12-05
Enrollment: 327
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Gestational diabetes

Primary outcomes:
measure: Number and Prevalence of Patients With Diabetic Retinopathy
timeFrame: At recruitment
measure: Number of Patients With Distal Diabetic Neuropathy
timeFrame: At recruitment
measure: Number of Patients With Chronic Kidney Disease (CKD)
timeFrame: At recruitment
measure: Number of Patients With Hypertension
timeFrame: At recruitment
measure: Number of Patients With Silent Myocardial Ischemia
timeFrame: At recruitment
measure: Number of Patients With Lower Extremity Artery Disease
timeFrame: At recruitment
measure: Number of Patients With Carotid Artery Stenosis
timeFrame: At recruitment
measure: Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index
timeFrame: At recruitment
measure: Number of Patients With Cardiac Autonomic Neuropathy
timeFrame: at recruitment
measure: Number of Patients With Bladder Autonomic Neuropathy
timeFrame: at recruitment
measure: Number of Patients With Gastro-intestinal Autonomic Neuropathy
timeFrame: at recruitment
measure: Number of Patients With Erectile Dysfunction
timeFrame: at recruitment
Secondary outcomes:
measure: Number of Patients With New Cardiac Events During Follow-up
timeFrame: One year after recruitment
measure: Number of Patients With New Stroke or Transient Ischemic Attack
timeFrame: One year after recruitment
measure: Number of Patients With Lower Limbs Atherothrombotic Accident
timeFrame: One year after recruitment
measure: Number of Patients That Died From Cardio Vascular Cause
timeFrame: One year after recruitment
Other outcomes:
Locations:
city: Ain - Taya
country: Algeria
facility: Internal Medicine department - Ain-Taya's Hospital
state: Algiers
Study officials:
affiliation: University of Algiers -Faculté de Medecine-
name: Ahmed Biad, professor
role: STUDY_DIRECTOR
affiliation: University of Algiers -Faculté de Médecine-
name: Wafia-Nadia Nibouche- Hattab, Ass-Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nibouche WN, Biad A. [Arterial hypertension at the time of diagnosis of type 2 diabetes in adults]. Ann Cardiol Angeiol (Paris). 2016 Jun;65(3):152-8. doi: 10.1016/j.ancard.2016.04.017. Epub 2016 May 24. French.