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Morbidity in Newly Diagnosed type2 Diabetes in Adults (MORNDIAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002091
Recruitment Status : Completed
First Posted : December 5, 2013
Results First Posted : September 14, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
National Institute of public Health, Algeria
Hopital Ain Taya
Parnet Hospital
Hôpital Mustapha Pacha
Birtraria Hospital
Bab El Oued Teaching Hospital
Information provided by (Responsible Party):
W.N. Nibouche-Hattab, University of Algiers

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.

Condition or disease Intervention/treatment
Type2 Diabetes Mellitus Complications Other: no specific treatment

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Study Type : Observational
Actual Enrollment : 327 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Micro and Macroangiopathy in Newly Diagnosed type2 Diabetic Adults in Suburban Area of Algiers
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. Number of Patients With Erectile Dysfunction [ Time Frame: at recruitment ]
    - Questionary: onset , drug use, medical history, psycho- social conditions


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples Without DNA
Blood. Urines. Tissue (kidney) for few patients.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002091


Locations
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Algeria
Internal Medicine department - Ain-Taya's Hospital
Ain - Taya, Algiers, Algeria, 16019
Sponsors and Collaborators
University of Algiers
National Institute of public Health, Algeria
Hopital Ain Taya
Parnet Hospital
Hôpital Mustapha Pacha
Birtraria Hospital
Bab El Oued Teaching Hospital
Investigators
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Study Director: Ahmed Biad, professor University of Algiers -Faculté de Medecine-
Principal Investigator: Wafia-Nadia Nibouche- Hattab, Ass-Prof University of Algiers -Faculté de Médecine-
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: W.N. Nibouche-Hattab, Assistant Professor, University of Algiers
ClinicalTrials.gov Identifier: NCT02002091    
Other Study ID Numbers: UAlgiers FM 401/desm/07
First Posted: December 5, 2013    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: August 28, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by W.N. Nibouche-Hattab, University of Algiers:
Type2 diabetes mellitus
Microangiopathy
Chronic Kidney disease
Cardiovascular disease
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases