Morbidity in Newly Diagnosed type2 Diabetes in Adults (MORNDIAB)
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|ClinicalTrials.gov Identifier: NCT02002091|
Recruitment Status : Completed
First Posted : December 5, 2013
Results First Posted : September 14, 2018
Last Update Posted : August 28, 2019
- 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|
|Study Type :||Observational|
|Actual Enrollment :||327 participants|
|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|
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.
- 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
- 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
- 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
- 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
- Number of Patients With Silent Myocardial Ischemia [ Time Frame: At recruitment ]
- 9 derivations resting electrocardiogram (ECG)
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Number of Patients With Erectile Dysfunction [ Time Frame: at recruitment ]- Questionary: onset , drug use, medical history, psycho- social conditions
- 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.
- 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.
- 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.
- 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
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
|Internal Medicine department - Ain-Taya's Hospital|
|Ain - Taya, Algiers, Algeria, 16019|
|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-|