Metabolic Syndrome Clinical Trial
— ILERVASOfficial title:
Randomized Intervention Study to Assess the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease and Its Impact on Morbidity and Mortality: The ILERVAS Project
Verified date | March 2024 |
Source | Institut de Recerca Biomèdica de Lleida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BACKGROUND AND OBJECTIVES: Cardiovascular disease is the leading cause of death despite huge primary and secondary prevention policies with a strong economic burden. The primary objectives of the ILERVAS project are: (i) to identify unknown factors involved in the presence of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (ii) to identify unknown factors involved in the progression of atherosclerosis, metabolic syndrome, pre-diabetes and hidden kidney disease in a low/moderate cardiovascular risk population; (iii) to Assess of the impact of arterial ultrasound on cardiovascular events and mortality in a low/moderate cardiovascular risk population. METHODS: Randomized intervention study. From 2015 to 2018, 16,660 participants (8,330 in the intervention group (Mobile Unit Follow-up Group) and 8,330 in the no intervention group (Electronic Medical History Follow-up Group )) aged between 45 and 70 years without a previous history of cardiovascular disease and with at least one cardiovascular risk factor will be randomly selected across the province of Lleida, Spain.
Status | Active, not recruiting |
Enrollment | 16660 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 70 Years |
Eligibility | Inclusion Criteria: - women (50-70 years) and men ( 45-65 years) with at least one cardiovascular risk factor (hypertension, dyslipidemia, obesity (BMI >30 Kg/m2), current smoking habit or former smoker (<10 years), first-degree family history of early cardiovascular disease). Exclusion Criteria: - Prior medical history of cardiovascular disease. - Diabetes. - Glomerular filtration rate (CKD-EPI < 60 ml/min/1.73m2). - Active neoplasm or acute disease. - A life expectancy < 18 months. - Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Spain | Fundació Renal Jaume Arnò | Lleida | |
Spain | Institut de recerca Biomèdica de Lleida | Lleida | |
Spain | Primary Care centre | Lleida |
Lead Sponsor | Collaborator |
---|---|
Institut de Recerca Biomèdica de Lleida | Diputació de Lleida, Jaume Arnó Renal Foundation, Lleida Primary health care, Unit of Detection and Treatment of Atherothrombotic diseases (UDETMA) |
Spain,
Betriu A, Farras C, Abajo M, Martinez-Alonso M, Arroyo D, Barbe F, Buti M, Lecube A, Portero M, Purroy F, Torres G, Valdivielso JM, Fernandez E. Randomised intervention study to assess the prevalence of subclinical vascular disease and hidden kidney disea — View Citation
Gutierrez-Carrasquilla L, Sanchez E, Hernandez M, Polanco D, Salas-Salvado J, Betriu A, Gaeta AM, Carmona P, Purroy F, Pamplona R, Farras C, Lopez-Cano C, Fernandez E, Lecube A. Effects of Mediterranean Diet and Physical Activity on Pulmonary Function: A — View Citation
Montserrat-Capdevila J, Seminario MA, Godoy P, Marsal JR, Ortega M, Pujol J, Castan MT, Alseda M, Betriu A, Lecube A, Portero M, Purroy F, Valdivielso JM, Barbe F. Prevalence of chronic obstructive pulmonary disease (COPD) not diagnosed in a population wi — View Citation
Sanchez E, Betriu A, Salas-Salvado J, Pamplona R, Barbe F, Purroy F, Farras C, Fernandez E, Lopez-Cano C, Mizab C, Lecube A; ILERVAS project investigators. Mediterranean diet, physical activity and subcutaneous advanced glycation end-products' accumulatio — View Citation
Sanchez E, Betriu A, Yeramian A, Fernandez E, Purroy F, Sanchez-de-la-Torre M, Pamplona R, Miquel E, Kerkeni M, Hernandez C, Simo R, Lecube A; ILERVAS project; ILERVAS Project:; Hernandez M, Rius F, Polanco D, Barbe F, Torres G, Suarez G, Portero-Otin M, — View Citation
Sanchez E, Gutierrez-Carrasquilla L, Barbe F, Betriu A, Lopez-Cano C, Gaeta AM, Purroy F, Pamplona R, Ortega M, Fernandez E, Hernandez C, Lecube A, Simo R; ILERVAS Project. Lung function measurements in the prediabetes stage: data from the ILERVAS Project — View Citation
Sanchez E, Lecube A, Betriu A, Hernandez C, Lopez-Cano C, Gutierrez-Carrasquilla L, Kerkeni M, Yeramian A, Purroy F, Pamplona R, Farras C, Fernandez E, Barbe F, Simo R; ILERVAS project; Hernandez M, Rius F, Polanco D, de la Torre MS, Torres G, Godoy P, Po — View Citation
Sanchez M, Sanchez E, Hernandez M, Gonzalez J, Purroy F, Rius F, Pamplona R, Farras-Salles C, Gutierrez-Carrasquilla L, Fernandez E, Bermudez-Lopez M, Salvador J, Salas-Salvado J, Lecube A; ILERVAS project collaborators. Dissimilar Impact of a Mediterrane — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of sociodemographic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in atherosclerosis, in a low/moderate cardiovascular risk population. | The presence of atherosclerosis will be identified as an intima-media thickness higher than 1.5 mm. | 4 years | |
Primary | Identification of sociodemographic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in pre-diabetes, in a low/moderate cardiovascular risk population. | The percentage of glycated hemoglobin (Hb A1c) will be determined with a Cobas b 101® machine (Roche). Values lower than 5.7% are normal, > 5.7-6.5% indicate pre-diabetes; and = 6.5% indicate diabetes. | 4 years | |
Primary | Identification of sociodemograpic, lifestyle, clinical, anthropometric, laboratory, climate and air pollutants factors involved in chronic kidney disease, in a low/moderate cardiovascular risk population. | The prevalence of hidden chronic kidney disease will be assessed with a urine spot test that determines the albumin/creatinine ratio (ACR). Values lower than 30 mg/g are normal; 30-300 mg/g indicate microalbuminuria; and values higher than 300 indicate macroalbuminuria. | 4 years | |
Primary | Assessment of the impact of arterial ultrasound on cardiovascular events and mortality in a low/moderate cardiovascular risk population. | The onset of a cardiovascular event will be recorded according to the tenth version of the International Statistical Classification of Diseases (ICD-10). Cardiovascular events and mortality in the intervention group will be compared to the control group during a during a 10-year follow-up period. | 10 years | |
Secondary | Prevalence of atherosclerosis in a low/moderate cardiovascular risk population | The presence of atherosclerosis will be identified as an intima-media thickness higher than 1.5 mm. | 4 years | |
Secondary | Prevalence of hidden chronic kidney disease in a low/moderate cardiovascular risk population. | The prevalence of hidden chronic kidney disease will be assessed with a urine spot test that determines the albumin/creatinine ratio (ACR). Values lower than 30 mg/g are normal; 30-300 mg/g indicate microalbuminuria; and values higher than 300 indicate macroalbuminuria. | 4 years | |
Secondary | Prevalence of pre-diabetes and undiagnosed diabetes in a low/moderate cardiovascular risk population. | The percentage of glycated hemoglobin (Hb A1c) will be determined with a Cobas b 101® machine (Roche). Values lower than 5.7% are normal; 5.7-6.5% indicate pre-diabetes; and = 6.5% indicate diabetes. | 4 years | |
Secondary | Correlation of skin autofluorescence with atherosclerosis in a low/moderate cardiovascular risk population. | Skin autofluorescence will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units. | 4 years | |
Secondary | Correlation of adherence to the Mediterranean diet with atherosclerosis in a low/moderate cardiovascular risk population. | Adherence to the Mediterranean diet will be evaluated with the Mediterranean Diet Adherence screener (MEDAS). Values are from 0 to 14 and categorize subjects according to their level of adherence: high (score >11 points), moderate (7-10 points), and low (<6 points). | 4 years | |
Secondary | Correlation of physical exercise with atherosclerosis in a low/moderate cardiovascular risk population. | Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). Values are from vigorous, moderate, and low physical activity. Low activity corresponds to no activity or some activity but not enough to meet moderate category. Moderate corresponds to 3 or more days of walking for at least 30 minutes. Vigorous activity corresponds to 5 or more days of walking for at least 60 minutes. | 4 years | |
Secondary | Prevalence of atrial fibrillation in a low/moderate cardiovascular risk population. | The presence of atrial fibrillation is assessed with stroke risk analysis device (SRA, EVINA Health Solutions). | 4 years | |
Secondary | Correlation of spirometry alterations with atherosclerosis in a low/moderate cardiovascular risk population | Forced vital capacity (FVC) will be measured as liters (l). | 4 years | |
Secondary | Correlation of advanced glycation end-products (AGEs) and cardiovascular events in a low/moderate cardiovascular risk population. | AGES will be analyzed with the AGE reader™ device (DiagnOptics Technologies, Groningen, The Netherlands). Values range from 1-24 units. | 10 years | |
Secondary | Correlation of adherence to the Mediterranean diet and cardiovascular events in a low/moderate cardiovascular risk population. | Adherence to the Mediterranean diet will be evaluated with the Mediterranean Diet Adherence screener (MEDAS). Values are from 0 to 14 and categorize subjects according to their level of adherence: high (score >11 points), moderate (7-10 points), and low (<6 points). | 10 years | |
Secondary | Correlation of physical exercise and cardiovascular events in a low/moderate cardiovascular risk population. | Physical exercise will be evaluated with the International Physical Activity Questionnaire (IPAQ). Values are from vigorous, moderate, and low physical activity. | 10 years | |
Secondary | Association of spirometry alterations and cardiovascular events in a low/moderate cardiovascular risk population | Forced vital capacity (FVC) will be measured as liters (l). | 10 years |
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