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Morbidity in Newly Diagnosed type2 Diabetes in Adults

Prevalence of Micro and Macroangiopathy in Newly Diagnosed type2 Diabetic Adults in Suburban Area of Algiers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02002091
Acronym
MORNDIAB
Enrollment
327
Registered
2013-12-05
Start date
2009-01-31
Completion date
2014-12-31
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Type2 Diabetes Mellitus

Keywords

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

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.

Detailed description

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 one of 12 primary care units of Ain-Taya's health sector in Est suburb of Algiers . When a glycemia is found at 1.26 g/litre or over, the patient is referred to principal investigator to confirm the diagnosis of type 2 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 * Khi-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.

Interventions

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

Sponsors

National Institute of public Health, Algeria
CollaboratorUNKNOWN
Hopital Ain Taya
CollaboratorOTHER
Parnet Hospital
CollaboratorOTHER
Hôpital Mustapha Pacha
CollaboratorOTHER
Birtraria Hospital
CollaboratorOTHER
Bab El Oued Teaching Hospital
CollaboratorOTHER
University of Algiers
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Gestational diabetes

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With Erectile Dysfunctionat recruitment\- Questionary: onset , drug use, medical history, psycho- social conditions
Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance IndexAt 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 Neuropathyat 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 Neuropathyat 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 Neuropathyat 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 and Prevalence of Patients With Diabetic RetinopathyAt 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 NeuropathyAt recruitmentAll 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)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 HypertensionAt 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 IschemiaAt 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
Number of Patients With Lower Extremity Artery DiseaseAt 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 StenosisAt 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.

Secondary

MeasureTime frameDescription
Number of Patients With New Stroke or Transient Ischemic AttackOne 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 AccidentOne year after recruitmentDuring 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 CauseOne 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.
Number of Patients With New Cardiac Events During Follow-upOne 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.

Countries

Algeria

Participant flow

Recruitment details

327 patients aged from 40 to 70 years were seen from 2009 to 2013. The main investigator confirmed the diagnosis of type 2 diabetes. A secondary diabetes was excluded before definitive recruitment. When the diagnosis of type 2 diabetes is highly probable and ensure that it was newly diagnosed, we screened for all chronic complications.

Participants by arm

ArmCount
Men Population
Screening for all chronic complications were performed for men. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin) treatment of comorbidity or complications of diabetes as soon as the patients are recruited.
122
Women Population
Screening for all chronic complications were performed for women. A non specific multi interventional treatment is applied to patients, as lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes as soon as the patients are recruited.
205
Total327

Withdrawals & dropouts

PeriodReasonFG000FG001
ScreeningDeath32
ScreeningLost to Follow-up1012

Baseline characteristics

CharacteristicTotalWomen PopulationMen Population
Age, Continuous53.5 years
STANDARD_DEVIATION 8.6
53.7 years
STANDARD_DEVIATION 8.4
53.4 years
STANDARD_DEVIATION 8.9
BMI28.0 kg/m²
STANDARD_DEVIATION 5.2
28.9 kg/m²
STANDARD_DEVIATION 5.1
26.6 kg/m²
STANDARD_DEVIATION 4.9
Diastolic blood pressure85.8 mm Hg
STANDARD_DEVIATION 11.7
85.3 mm Hg
STANDARD_DEVIATION 10.9
86.6 mm Hg
STANDARD_DEVIATION 13
Glycaemia2.50 g/l
STANDARD_DEVIATION 1.01
2.39 g/l
STANDARD_DEVIATION 0.98
2.70 g/l
STANDARD_DEVIATION 1.05
glycated hemoglobin9.58 percent
STANDARD_DEVIATION 2.29
9.48 percent
STANDARD_DEVIATION 2.38
9.73 percent
STANDARD_DEVIATION 2.16
history of family diabetes222 participants138 participants84 participants
history of family hypertension202 participants133 participants69 participants
Region of Enrollment
Algeria
327 participants205 participants122 participants
Sex: Female, Male
Female
205 Participants205 Participants0 Participants
Sex: Female, Male
Male
122 Participants0 Participants122 Participants
Systolic blood pressure141.2 mm Hg
STANDARD_DEVIATION 23.4
141.9 mm Hg
STANDARD_DEVIATION 23.9
139.9 mm Hg
STANDARD_DEVIATION 22.6
waist circumference98.9 cm
STANDARD_DEVIATION 10.7
99.3 cm
STANDARD_DEVIATION 10.8
98.1 cm
STANDARD_DEVIATION 10.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 1124 / 193
other
Total, other adverse events
18 / 10929 / 191
serious
Total, serious adverse events
3 / 1094 / 191

Outcome results

Primary

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

Time frame: At recruitment

Population: From 327, 309 (113 men and 196 women) patients benefit from ophthalmoscopy with a trained ophthalmologist. 18 patients (9 men and 9 women) didn't perform the test. Each patient having a diabetic retinopathy was treated by the ophtalmologist who performed the examination

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber and Prevalence of Patients With Diabetic Retinopathy9 Participants
Women GroupNumber and Prevalence of Patients With Diabetic Retinopathy18 Participants
p-value: 0.706Chi-squared
Primary

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.

Time frame: at recruitment

Population: From 327 we could screen 318 patients (118 men and 200 women) for bladder autonomic neuropathy. We performed a cystomanometry in 4 patients. We exclude, from analysis, 9 patients who didn't come to perform the post-voiding volume measurement.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Bladder Autonomic Neuropathy5 Participants
Women GroupNumber of Patients With Bladder Autonomic Neuropathy11 Participants
p-value: 0.816Chi-squared, Corrected
Primary

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

Time frame: at recruitment

Population: We screened 283 patients from 327 (100 men and 183 women). We excluded 44 patients from analysis (22 men and 22 women)cause of beta blocker treatment or high blood pressure, or diabetic retinopathy, or severe coronary heart disease and patients that could not perform deep breathing.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Cardiac Autonomic Neuropathy10 Participants
Women GroupNumber of Patients With Cardiac Autonomic Neuropathy19 Participants
p-value: 0.917Chi-squared, Corrected
Primary

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.

Time frame: At recruitment

Population: From 327, 304 patients (109 men and 195 women) could perfom duplex ultrasonography of supra aortic trunks. We focus on the examination of external and internal carotids.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Carotid Artery Stenosis7 Participants
Women GroupNumber of Patients With Carotid Artery Stenosis3 Participants
p-value: 0.038Fisher Exact
Primary

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

Time frame: At recruitment

Population: Of 327 patients, 317 had a complete screening for chronic kidney disease, 5 men and 5 women were excluded from analysis because of incomplete renal status.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Chronic Kidney Disease (CKD)35 Participants
Women GroupNumber of Patients With Chronic Kidney Disease (CKD)43 Participants
p-value: 0.123Mantel Haenszel
Primary

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

Time frame: At recruitment

Population: We exclude from analysis 10 patients (2 men and 8 women) with neuropathy because of other possible etiology (8 hypothyroidism, 1 with B12 deficiency,1 with narrowed lumbar vertebra channel)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Distal Diabetic Neuropathy42 Participants
Women GroupNumber of Patients With Distal Diabetic Neuropathy56 Participants
p-value: 0.346Chi-squared
Primary

Number of Patients With Erectile Dysfunction

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

Time frame: at recruitment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Erectile Dysfunction63 Participants
Primary

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.

Time frame: at recruitment

Population: An endoscopic examination has been performed in six women whose report vomiting, nausea or constipation. In the men's group no-one had an endoscopic examination.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Gastro-intestinal Autonomic Neuropathy0 Participants
Women GroupNumber of Patients With Gastro-intestinal Autonomic Neuropathy6 Participants
p-value: 0.008Fisher Exact
Primary

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

Time frame: At recruitment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Hypertension82 Participants
Women GroupNumber of Patients With Hypertension136 Participants
p-value: 0.968Chi-squared, Corrected
Primary

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.

Time frame: At recruitment

Population: Lower limb duplex ultrasonography measurement has been done in 306 among 327 patients (111 men and 195 women). 21 patients, with a lack of data,were excluded from analysis. Chi 2 test was used for comparison of proportions.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Lower Extremity Artery Disease6 Participants
Women GroupNumber of Patients With Lower Extremity Artery Disease12 Participants
p-value: 0.988Fisher Exact
Primary

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.

Time frame: At recruitment

Population: From 327 we perform a duplex ultrasonography of renal arteries in 16 patients (6 men and 10 women) The number of participants analyzed is too small to have a statistical analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index2 Participants
Women GroupNumber of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index2 Participants
Primary

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

Time frame: At recruitment

Population: 88.9 % (291 patients) had a screening for coronary heart disease. We performed an electrocardiogram in 325 cases, an echocardiography in 317 cases, a myocardial ischemic test in 291 cases (223 for silent myocardial ischemia: 85 men and 138 women) and a coronarography in 18 cases ( 8 men and 10 women, all had a positive myocardial ischemic test)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Silent Myocardial Ischemia11 Participants
Women GroupNumber of Patients With Silent Myocardial Ischemia4 Participants
p-value: 0.004Fisher Exact
Secondary

Number of Patients That Died From Cardio Vascular Cause

\- 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.

Time frame: One year after recruitment

Population: From 327 patients (122 men and 205 women) enrolled, 305 were followed-up one year or until death (112 men and 193 women). 22 patients (10 men and 12 women) were excluded from analysis because lost during follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients That Died From Cardio Vascular Cause3 Participants
Women GroupNumber of Patients That Died From Cardio Vascular Cause2 Participants
p-value: 0.059Fisher Exact
Secondary

Number of Patients With Lower Limbs Atherothrombotic Accident

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.

Time frame: One year after recruitment

Population: 300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data, 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With Lower Limbs Atherothrombotic Accident0 Participants
Women GroupNumber of Patients With Lower Limbs Atherothrombotic Accident1 Participants
Secondary

Number of Patients With New Cardiac Events During Follow-up

* 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.

Time frame: One year after recruitment

Population: 305 patients (112 men and 193 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 22 patients (10 men and 12 women) from the analysis because of a lack of data, they were lost from follow-up. We include in analysis 5 patients who died the three first months during follow-up.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With New Cardiac Events During Follow-up7 Participants
Women GroupNumber of Patients With New Cardiac Events During Follow-up2 Participants
p-value: 0.025Chi-squared, Corrected
Secondary

Number of Patients With New Stroke or Transient Ischemic Attack

* 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.

Time frame: One year after recruitment

Population: 300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data. 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Men GroupNumber of Patients With New Stroke or Transient Ischemic Attack1 Participants
Women GroupNumber of Patients With New Stroke or Transient Ischemic Attack2 Participants

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026