Morbidity in Newly Diagnosed type2 Diabetes in Adults (MORNDIAB)

June 8, 2024 updated by: W.N. Nibouche-Hattab, University of Algiers

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

  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
    • Algiers
      • Ain - Taya, Algiers, Algeria, 16019
        • Internal Medicine department - Ain-Taya's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Gestational diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: no specific treatment
lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and Prevalence of Patients With Diabetic Retinopathy
Time Frame: At recruitment
  • Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office.
  • Retinal angiography was performed if indicated by the ophtalmologist
At recruitment
Number of Patients With Distal Diabetic Neuropathy
Time Frame: At recruitment

All 327 patients had a neurological examination by the same physician to screen for Distal Diabetic Neuropathy:

  • Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception
  • Ankles and knees reflex testing
  • Muscle strength testing (quadriceps and tibialis anterior)
  • We use the Michigan Neuropathy Screening Instrument score. We consider the diagnosis of Distal Diabetic Neuropathy if the score is up of 2 in at least one food. The MNSI score is ranged from 0 to 5 for each food
  • Use of neuropathic pain score (DN4), if the DN4 is found up or egal to 4 we consider the diagnosis of neuropathic pain. The DN4 score is ranged from 0 to 10
At recruitment
Number of Patients With Chronic Kidney Disease (CKD)
Time Frame: At recruitment
  • We screened for albuminuria or microalbuminuria in 24h urine collection with turbidimetry or immuno turbidimetry method ( performed 3 times in 4 or 6 months )
  • Measurement of albumine- to- creatinine ratio (ACR), Albuminuria was diagnosed if ACR > or egal to 30 mg/g at least twice in 4 to 6 months. We ensure before performing ACR that there was no dysglycaemia, no urinary infection, no fever nor forced diuresis before we evaluate the urine sample.
  • Cyto bacteriological examination and urine culture
  • Serum creatinine repeated 2 to 3 time within 4 to 6 months
  • Glomerular filtration rate was assessed with the Modification of Diet in Renal disease study equation (MDRD)
  • Renal and urine tract echography to measure the kidneys and to screen for urine tract dilatation We made the diagnosis of Chronic Kidney Disease (CKD) if the glomerular filtration rate was < 60 ml/min/1.73 m² and/or ACR > or equal to 30 mg/g with a permanent character
At recruitment
Number of Patients With Hypertension
Time Frame: At recruitment
  • Blood pressure measurement by electronic tensiometer (OMRON 3 or 4) on the right and left arm, after 10 mn of supine position.
  • Three measures were performed with respect of one minute interval between each measure.
  • Mean blood pressure is calculated
  • Three other measures are performed in Three ulterior consultations
  • Hypertension is diagnosed if the mean blood pressure >= 140 /90 mm Hg
At recruitment
Number of Patients With Silent Myocardial Ischemia
Time Frame: At recruitment
  • 9 derivations resting electrocardiogram (ECG)
  • Echocardiography
  • Standard ECG stress test
  • Stress Myocardial Perfusion scintigraphy if patients are not able to perform ECG stress test
  • Coronary angiography if the exercise ECG stress test or stress myocardial perfusion scintigraphy suggest high probability of coronary heart disease
At recruitment
Number of Patients With Lower Extremity Artery Disease
Time Frame: At recruitment
  • Search for history of intermittent claudication
  • Complete vascular examination with Ankle-Brachial Index (ABI) measurement.
  • Lower limb duplex ultrasonography.
At recruitment
Number of Patients With Carotid Artery Stenosis
Time Frame: At recruitment
  • Screening for carotid murmur at clinical examination by the same physician for all patients
  • Carotid duplex ultrasonography with intima-media thickness measurement. All atherosclerotic lesions were reported.
At recruitment
Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index
Time Frame: At recruitment
- Renal artery duplex ultrasonography has been performed only if the patient presents a resistant hypertension treated with four drugs, including a diuretic or if blood pressure was over 180/10 mm Hg at recruitement.
At recruitment
Number of Patients With Cardiac Autonomic Neuropathy
Time Frame: at recruitment
  • Conditions of the Ewing tests: fasting, resting at least 30mn, no hypoglycemia and no effort within 24hours, no drugs that interfere with heart rate.
  • Ewing Tests for cardiac autonomic neuropathy: Beat-to-Beat heart rate variation, Heart rate response to standing, Heart rate response to valsalva maneuver, Systolic blood pressure response to standing. All tests have been performed with the same physician and aid
at recruitment
Number of Patients With Bladder Autonomic Neuropathy
Time Frame: at recruitment
  • History of recurrent urine tract infection and/or dysuria and/or incomplete bladder emptying
  • Post voiding residual(PVR) measurement with abdominal echography by a radiologist
  • Cystomanometry is performed if PVR > 50 ml
  • In men the prostatic measurement was made in all patients. In women, we measured the volume of uterus.
at recruitment
Number of Patients With Gastro-intestinal Autonomic Neuropathy
Time Frame: at recruitment
  • We interviewed all patient, looking for a history of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation
  • We performed an endoscopic examination to exclude other causes in patients with a positive history of gastro-intestinal troubles.
at recruitment
Number of Patients With Erectile Dysfunction
Time Frame: at recruitment
- Questionary: onset , drug use, medical history, psycho- social conditions
at recruitment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients With New Cardiac Events During Follow-up
Time Frame: One year after recruitment
  • We Record every documented acute coronary syndrome during follow-up;
  • Each patient had an electrocardiogram every 3 months and during acute cardiovascular events;
  • Echocardiography has been performed if indicated by the cardiologist.
One year after recruitment
Number of Patients With New Stroke or Transient Ischemic Attack
Time Frame: One year after recruitment
  • We assessed every new clinical signs of stroke with an interview searching for acute neurological symptoms and a clinical examination for all patients, from day one of recruitment to one year of follow-up;
  • Tomodensitometry if there was a clinical presentation of stroke. Magnetic resonance imaging if transient ischemic attack was suspected.
One year after recruitment
Number of Patients With Lower Limbs Atherothrombotic Accident
Time Frame: One year after recruitment

During one year of follow-up :

  • We search for a recent history of intermittent claudication;
  • We perform a systematic clinical examination with palpation of lower limb pulses and an Ankle-Brachial Index measurement after one year or in the presence of an acute ischemic lower limb episod ;
  • Lower limb duplex sonography in the presence of an abnormal clinical vascular examination;
  • Angiography in the presence of a lower limbs vascular event.
One year after recruitment
Number of Patients That Died From Cardio Vascular Cause
Time Frame: One year after recruitment
- We recorded each death and its cause from a medical record after hospitalization in emergency units or phone contact with the patient's relatives to have some news. The record began with recruitment.
One year after recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Algiers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of public Health, Algeria
Hopital Ain Taya
Parnet Hospital
Hôpital Mustapha Pacha
Birtraria Hospital
Bab El Oued Teaching Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahmed Biad, professor, University of Algiers -Faculté de Médecine-
  • Principal Investigator: Wafia-Nadia Nibouche- Hattab, Ass-Prof, University of Algiers -Faculté de Médecine-

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UAlgiers FM 401/desm/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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