Morbidity in Newly Diagnosed type2 Diabetes in Adults

NCT ID: NCT02002091

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Type2 Diabetes Mellitus; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Complications,no specific treatment

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.

no specific treatment

Intervention Type: OTHER

lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.

Interventions

no specific treatment

lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of public Health, Algeria

UNKNOWN

Sponsor Role: collaborator

Hopital Ain Taya

OTHER

Sponsor Role: collaborator

Parnet Hospital

OTHER

Sponsor Role: collaborator

Hôpital Mustapha Pacha

OTHER

Sponsor Role: collaborator

Birtraria Hospital

OTHER

Sponsor Role: collaborator

Bab El Oued Teaching Hospital

OTHER

Sponsor Role: collaborator

University of Algiers

OTHER

Sponsor Role: lead

Responsible Party

W.N. Nibouche-Hattab

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Biad, professor

Role: STUDY_DIRECTOR

University of Algiers -Faculté de Medecine-

Wafia-Nadia Nibouche- Hattab, Ass-Prof

Role: PRINCIPAL_INVESTIGATOR

University of Algiers -Faculté de Médecine-

Locations

Internal Medicine department - Ain-Taya's Hospital

Aïn Taya, Algiers Province, Algeria

Countries

Algeria

References

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.

Reference Type: DERIVED

PMID: 27234335 (View on PubMed)

Other Identifiers

UAlgiers FM 401/desm/07

Identifier Type: -

Identifier Source: org_study_id