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Type2 Diabetes MellitusMORNDIABNCT02002091

Morbidity in Newly Diagnosed type2 Diabetes in Adults

An observational study of Type2 Diabetes Mellitus and Complications, run by University of Algiers at 1 site in Algeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Type2 Diabetes Mellitus, Complications
What is being tested?
no specific treatment
Type of treatment
Pill or oral medicine
How many people
327 participants
Where
1 siteAlgeria
Study dates
Jan 2009to Dec 2014
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Gestational diabetes

Trial locations and contacts

1 site in 1 country.

Algeria1 site

  • Internal Medicine department - Ain-Taya's Hospital

    Aïn Taya, Algiers Province, 16019

Other trials in Algeria

About this study

Official title: 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.
Read the 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.
Being tested
no specific treatment
Keywords
Type2 diabetes mellitus, Microangiopathy, Chronic Kidney disease, Cardiovascular disease
Medical subject headings
Renal Insufficiency, Chronic, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no specific treatmentOther

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

Study groups in NCT02002091
Study groupRoleWhat they receive
Complications,no specific treatmentAfter 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.
Receives: Other: no specific treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Prevalence of Patients With Diabetic Retinopathy

    • 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

    Measured: At recruitment

  2. Number of Patients With Distal Diabetic Neuropathy

    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

    Measured: At recruitment

  3. Number of Patients With Chronic Kidney Disease (CKD)

    • 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

    Measured: At recruitment

  4. Number of Patients With Hypertension

    • 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

    Measured: At recruitment

  5. Number of Patients With Silent Myocardial Ischemia

    • 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

    Measured: At recruitment

  6. Number of Patients With Lower Extremity Artery Disease

    • Search for history of intermittent claudication
    • Complete vascular examination with Ankle-Brachial Index (ABI) measurement.
    • Lower limb duplex ultrasonography.

    Measured: At recruitment

  7. Number of Patients With Carotid Artery Stenosis

    • 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.

    Measured: At recruitment

  8. Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index

    • 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.

    Measured: At recruitment

  9. Number of Patients With Cardiac Autonomic Neuropathy

    • 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

    Measured: at recruitment

  10. Number of Patients With Bladder Autonomic Neuropathy

    • 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.

    Measured: at recruitment

  11. Number of Patients With Gastro-intestinal Autonomic Neuropathy

    • 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.

    Measured: at recruitment

  12. Number of Patients With Erectile Dysfunction

    • Questionary: onset , drug use, medical history, psycho- social conditions

    Measured: at recruitment

Secondary outcomes (4)

  1. Number of Patients With New Cardiac Events During Follow-up

    • 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.

    Measured: One year after recruitment

  2. Number of Patients With New Stroke or Transient Ischemic Attack

    • 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.

    Measured: One year after recruitment

  3. Number of Patients With Lower Limbs Atherothrombotic Accident

    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.

    Measured: One year after recruitment

  4. Number of Patients That Died From Cardio Vascular Cause

    • 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.

    Measured: One year after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2013 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02002091
Sponsor's protocol ID
UAlgiers FM 401/desm/07
Acronym
MORNDIAB
Status last verified
Jun 2024
First submitted
28 Nov 2013
Last updated
21 Jun 2024
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27234335

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes Mellitus and Complications, run by University of Algiers at 1 site in Algeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Prevalence of Patients With Diabetic Retinopathy (time frame: At recruitment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02002091, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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