Prevalence of Morbidity in Newly Diagnosed type2 Diabetes in Adults
|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
Last Update Posted : March 20, 2015
- 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|
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 primary care structures. When a glycemia is found at 1.26 g/litre or over, the patient is referred to principal investigator to confirm the type2 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
- Chi-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 :||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.
- Screening for diabetic retinopathy [ Time Frame: At recruitment ]
- Ophthalmoscopy with a trained ophthalmologist
- Retinal angiography if necessary
- Screening for Distal Diabetic Neuropathy [ Time Frame: At recruitment ]
- Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception
- Ankle reflex testing
- Muscle strength testing (quadriceps and tibialis anterior)
- Use of Michigan Neuropathy Screening Instrument (MNSI) for the diagnosis of confirmed diabetic neuropathy.
- Use of neuropathic pain score (DN4)
- Screening for Chronic Kidney Disease (CKD) [ Time Frame: At recruitment ]
- Screening 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)
- Cyto bacteriological examination and urines culture
- Serum creatinine
- Glomerular filtration rate is assessed with the Modification of Diet in Renal disease study equation (MDRD)
- Renal and urine tract echography
- Screening for Hypertension [ Time Frame: At recruitment ]
- Blood pressure measurement by electronic tensiometer (OMRON4) on right and left arms, after 10 mn of supine position.
- Three measures are performed with respect of one minute interval between each measure.
- Mean blood pressure is calculated
- Three other measures are performed in ulterior consultations
- Screening for 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 exercise ECG test or stress myocardial perfusion scintigraphy suggest high risk coronary heart disease
- Screening for lower extremity artery Disease [ Time Frame: At recruitment ]
- Complete vascular examination with Ankle-Brachial Index measure.
- Lower limb duplex ultrasonography
- Screening for carotid artery disease [ Time Frame: At recruitment ]
- Screening for carotid murmur
- Carotid duplex ultrasonography with intima-media thickness measurement
- Screening for renal artery stenosis [ Time Frame: At recruitment ]- Renal artery duplex ultrasonography if resistant hypertension
- Screening for cardiac autonomic Neuropathy [ Time Frame: at recruitment ]
- Conditions: 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.
- Screening for 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.
- Cystomanometry is performed if PVR > 50 ml
- Screening for gastro-intestinal autonomic neuropathy [ Time Frame: at recruitment ]
- History of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation
- Endoscopic examination is performed to exclude other causes than gastro-intestinal autonomic neuropathy
- Screening for erectile dysfunction [ Time Frame: at recruitment ]- Questionary: onset , drug use, medical history, psycho- social conditions
- Screening for new cardiac events [ Time Frame: One year after recruitment ]
- Record every documented acute coronary syndrome during follow-up
- Screening for new stroke or Transient ischemic attack [ Time Frame: One year after recruitment ]
- Clinical signs of stroke.
- Tomodensitometry or magnetic resonance imaging.
- Screening for lower limb atherothrombotic accident [ Time Frame: One year after recruitment ]
- Recent history of intermittent claudication.
- Palpation of lower limb pulses
- Ankle-brachial index measurement.
- Lower limb duplex sonography if necessary
- Assess cardio vascular mortality [ Time Frame: One year after recruitment ]- Record each death and its cause
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 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-|