Morbidity in Newly Diagnosed type2 Diabetes in Adults

NCT02002091 | Completed Results DMC

• 1 other identifier: UAlgiers FM 401/desm/07
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus; Complications

Keywords

Type2 diabetes mellitus; Microangiopathy; Chronic Kidney disease; Cardiovascular disease

Outcome Measures

Primary Outcomes (12)

• 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

  At recruitment

• 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

  At recruitment

• 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

  At recruitment

• 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

  At recruitment

• 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

  At recruitment

• 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.

  At recruitment

• 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.

  At recruitment

• 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.

  At recruitment

• 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

  at recruitment

• 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.

  at recruitment

• 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.

  at recruitment

• Number of Patients With Erectile Dysfunction

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

  at recruitment

Secondary Outcomes (4)

• Number of Patients With New Cardiac Events During Follow-up

  One year after recruitment

• Number of Patients With New Stroke or Transient Ischemic Attack

  One year after recruitment

• Number of Patients With Lower Limbs Atherothrombotic Accident

  One year after recruitment

• Number of Patients That Died From Cardio Vascular Cause

  One year after recruitment

Study Arms (1)

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

Interventions

no specific treatment OTHER

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

Complications,no specific treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Gestational diabetes

Sponsors & Collaborators

• University of Algiers: lead
• National Institute of public Health, Algeria: collaborator
• Hopital Ain Taya: collaborator
• Parnet Hospital: collaborator
• Hôpital Mustapha Pacha: collaborator
• Birtraria Hospital: collaborator
• Bab El Oued Teaching Hospital: collaborator

Study Sites (1)

Internal Medicine department - Ain-Taya's Hospital

Aïn Taya, Algiers Province, 16019, Algeria

Location

Related Publications (1)

• 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.

  PMID: 27234335 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Wafia- Nadia Nibouche-Hattab
• Organization: Algiers' university -1- Benyoucef Benkhedda, Faculty of Medicine Meherzi, Algiers.

wani16000@yahoo.fr

+213771810932

Study Officials

• Ahmed Biad, professor

  University of Algiers -Faculté de Medecine-

  STUDY DIRECTOR

• Wafia-Nadia Nibouche- Hattab, Ass-Prof

  University of Algiers -Faculté de Médecine-

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 5, 2013
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 21, 2024
• Results First Posted: September 14, 2018

Record last verified: 2024-06

Locations

AL (1)