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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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13 May 2019 |
Main ID: |
ISRCTN16657699 |
Date of registration:
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12/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Low-density lipoprotein receptor-related protein 1 (LRP1) expression in Mexican hypertensive patients
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Scientific title:
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Monocyte low-density lipoprotein receptor-related protein 1 (LRP1) expression correlates with intima-media thickening in Mexican hypertensive patients |
Date of first enrolment:
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24/07/2013 |
Target sample size:
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200 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN16657699 |
Study type:
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Observational |
Study design:
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Single-center observational case-control study (Screening)
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Phase:
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Not Applicable
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Claudia
Huesca-Gomez |
Address:
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Juan Badiano No 1
Col. Sección XVI
C.P.14080
14080
México City
Mexico |
Telephone:
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(52-55) 55 73 29 11 Ext.1278 |
Email:
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c_huesca@yahoo.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Control group: 1. Normal pressure up to 120/80 mmHg 2. Mexican by birth, with at least two previous generations of Mexican origin 3. Agree to participate in the research protocol 4. Age 40-70 years
Hypertensive group: 1. Blood pressure > 140/90mmHg 2. Mexican by birth, with at least two previous generations of Mexican origin 3. Agree to participate in the research protocol
Exclusion criteria: Control group: 1. Have a history of cardiovascular disease 2. Have type 1 or 2 diabetes. 3. Have a chronic degenerative disease 4. Treatment with lipid-lowering medications
Hypertensive group: 1. Treatment with lipid-lowering medications 2. Have type 1 or 2 diabetes 3. Have a chronic degenerative disease
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arterial hypertension Circulatory System Essential (primary) hypertension
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Intervention(s)
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The population is recruited from the outpatient Service of the National Institute of Cardiology "Ignacio Chavez", where the hypertension diagnosis was made by a medical specialist. The subjects underwent anthropometric measurements determining their height in meters (m) weight in kilograms (kg). Blood pressure is measured using a mercury sphygmomanometer following the recommendations of the VII Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VII). Systolic and diastolic blood pressures are measured after rest for at least 10 min, and the average of the second and third measurements is recorded for analysis. Hypertension is defined as systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg or a previous clinical diagnosis of essential hypertension.
A specialist in sonography resolution assesses the intima/media thickness in the carotid artery, all measurements are performed with a Sonosite Micromax ultrasound device coupled to a 13 MHz multifrequency high-resolution linear transducer.
Blood samples were collected after a fasting period of 12 hours. Commercial enzymatic methods were used to determine circulating TC and TG, HDL-C, LDL-C. Angiotensin II was determined by capillary electrophoresis and C-reactive protein was determined by nephelometry. Peripheral blood mononuclear cell (PBMCs) are isolated from blood collected in EDTA using the Ficoll separation method.
Total RNA was extracted using monocyte TripureTM isolation reagent (Roche Molecular Biochemicals) followed by a reverse transcription reaction.
LRP1 gene expression and HPRT (endogenous gene) were quantified using a commercial kits "TaqMan Gene Expression" employing 7300 Real Time PCR System (Applied Biosystems) equipment. Total protein was extracted from monocytes using TriPureTM reagent (Roche Molecular Biochemicals). Membranes were incubated with
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Primary Outcome(s)
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1. Blood pressure (normotensive or hypertensive), measured using a mercury sphygmomanometer at 10 months 2. LRP1 gene expression, quantified using a "TaqMan Gene Expression" commercial kit and 7300 Real Time PCR System at 3 months 3. LRP1 protein, analyzed by western blot at 6 months 4. The intima/media thickness in the carotid artery, assessed with a Sonosite Micromax ultrasound device coupled to a 13 MHz multifrequency high-resolution linear transducer at 10 months
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Secondary ID(s)
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JTRM-D-16-00728
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Source(s) of Monetary Support
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Consejo Nacional de Ciencia y Tecnología
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Ethics review
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Status:
Approval date:
Contact:
Commission of bioethics of the INC Ignacio Chavez, 16/03/2010, ref: 10-665
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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25/07/2014 |
URL:
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