Prevalence of Morbidity in Newly Diagnosed type2 Diabetes in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of public Health, Algeria
Ain-Taya's hospital, Algiers
Parnet's teaching Hospital, Algiers
Mustapha Pacha's teaching hospital, Algiers
Birtraria's teaching hospital, Algiers
Bab el Oued's teaching hospital, Algiers
Clinica group,Contract Research Organization, Algiers
Information provided by (Responsible Party):
W.N. Nibouche-Hattab, University of Algiers
ClinicalTrials.gov Identifier:
NCT02002091
First received: November 28, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose
  • 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 Intervention
Type2 Diabetes Mellitus
Complications
Other: no specific treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Micro and Macroangiopathy in Newly Diagnosed type2 Diabetic Adults in Suburban Area of Algiers

Resource links provided by NLM:


Further study details as provided by University of Algiers:

Primary Outcome Measures:
  • Screening for diabetic retinopathy [ Time Frame: At recruitment ] [ Designated as safety issue: No ]
    • Ophthalmoscopy with a trained ophthalmologist
    • Retinal angiography if necessary

  • Screening for Distal Diabetic Neuropathy [ Time Frame: At recruitment ] [ Designated as safety issue: No ]

    Distal Polyneuropathy:

    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 exercise ECG test or stress myocardial perfusion scintigraphy suggest high risk coronary heart disease

  • Screening for lower extremity artery Disease [ Time Frame: At recruitment ] [ Designated as safety issue: No ]
    • Complete vascular examination with Ankle-Brachial Index measure.
    • Lower limb duplex ultrasonography

  • Screening for carotid artery disease [ Time Frame: At recruitment ] [ Designated as safety issue: No ]
    • Screening for carotid murmur
    • Carotid duplex ultrasonography with intima-media thickness measurement

  • Screening for renal artery stenosis [ Time Frame: At recruitment ] [ Designated as safety issue: No ]
    - Renal artery duplex ultrasonography if resistant hypertension

  • Screening for cardiac autonomic Neuropathy [ Time Frame: at recruitment ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    - Questionary: onset , drug use, medical history, psycho- social conditions


Secondary Outcome Measures:
  • Screening for new cardiac events [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    • Record every documented acute coronary syndrome during follow-up
    • Electrocardiogram
    • Echocardiography

  • Screening for new stroke or Transient ischemic attack [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    • Clinical signs of stroke.
    • Tomodensitometry or magnetic resonance imaging.

  • Screening for lower limb atherothrombotic accident [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    - Record each death and its cause


Biospecimen Retention:   Samples Without DNA

Blood. Urines. Tissue (kidney) for few patients.


Enrollment: 327
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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 between 40 and 70 years
  • Newly diagnosed type 2 diabetes
  • Never treated for diabetes

Exclusion Criteria:

  • Gestational diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002091

Locations
Algeria
Internal Medicine department - Ain-Taya Hospital-
Ain - Taya, Algiers, Algeria, 16019
Sponsors and Collaborators
University of Algiers
National Institute of public Health, Algeria
Ain-Taya's hospital, Algiers
Parnet's teaching Hospital, Algiers
Mustapha Pacha's teaching hospital, Algiers
Birtraria's teaching hospital, Algiers
Bab el Oued's teaching hospital, Algiers
Clinica group,Contract Research Organization, Algiers
Investigators
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-
  More Information

No publications provided

Responsible Party: W.N. Nibouche-Hattab, Assistant Professor, University of Algiers
ClinicalTrials.gov Identifier: NCT02002091     History of Changes
Other Study ID Numbers: UAlgiers FM 401/desm/07
Study First Received: November 28, 2013
Last Updated: September 2, 2014
Health Authority: Algeria: Ministry of University Education and Scientific Research

Keywords provided by University of Algiers:
Type2 diabetes mellitus
Microangiopathy
Chronic Kidney disease
Cardiovascular disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014