Depression Clinical Trial
— ESSENTIALOfficial title:
Essential Arterial Hypotension and Allostasis Registry
NCT number | NCT02018497 |
Other study ID # | LEMD001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1995 |
Est. completion date | June 30, 2024 |
The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities. To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered. HYPOTHESIS The causes of the diseases are multifactorial. Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process. A person´s health depends on their: 1. Biological and physiologic systems 2. External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain. 3. Their interaction. The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by: 1. Functional systems; mediated by: 1. The Autonomic Nervous System 2. The endocrine system 3. The immune system 2. Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in: 1. Epigenetic, endophenotypes, polyphenism. 2. Plasticity 3. The interaction between a) and b). The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment. The allostatic model defines health as a state of responsiveness. The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude. Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function. Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Any patient regardless of the age of gender Exclusion Criteria: - Any non-correctable secondary cause of increase or decrease in blood pressure - or a pathology that alters the prognosis before the entrance of the patient into this registry. - nephropathy prior to the admission, - familial dyslipidemia, - previous gastric bypass, - pre-existing heart failure, - chemotherapy-induced cardiotoxicity, - arrhythmogenic right ventricular dysplasia, - long QT syndrome, - hypertrophic cardiomyopathy - restrictive cardiomyopathy or sudden death syndromes other than coronary disease - Down syndrome, - having one single kidney before entering to this registry, - polycystic kidney, - disability to continue with the treatment - organ transplantation (other than cornea), - HIV positive, - homocystinuria, - myelomeningocele, - autoimmune diseases, - paraplegia, - chronic infections (TB), - myocarditis of any cause, - blood dyscrasia with coagulation disorders, - history of pulmonary embolism, - sustained or non-sustained ventricular tachycardia, - idiopathic tachycardia associated with syncope which is not cured by radiofrequency ablation, - pulmonary hypertension, - diabetes insipidus, - COPD, - Gitelman syndrome, - Cervical cancer associated with human Papillomavirus, - multiple sclerosis, - hemochromatosis, - not compact ventricle. It is important to emphasize that all of these patients, currently excluded from the registry, may be studied in the future, they keep on follow-up and taken 6 BP. Additionally it is planned to compare the evolution of patients with secondary causes of hypertension or hypotension with essential disorders |
Country | Name | City | State |
---|---|---|---|
Colombia | CES University | Medellín | Antioquia |
Lead Sponsor | Collaborator |
---|---|
CES University |
Colombia,
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LE Medina, Aristizabal D, McEween J, W Uribe, Duque M, Marín J Gil E, Bravo D, Gonzalez E, Restrepo MA, Torres Y, Cotes JM. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Are there insulin sensitivity differences expected along the blood pressure spectrum? 17th International symposium on the autonomic nervous system. Westin Riomar, Rio Grande, Puerto Rico, November 1-4 2006. Clinical Autonomic Research. Vol 16, number 5, page 332, 2006. Summary
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LE Medina, J Ospina, MA Lemos, G Cuartas, D Aristizabal, J Calle, Gutierrez, Y Torres. Relationship between blood pressure, depression and anxiety. A step into the concept of psychobiotype (mind-body relationship). Clinical Autonomic Research. Vol 18, number 5, page 277, 2008. Summary
LE Medina, M Duque, J Marín, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizabal, W Uribe. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. Are there differences in the variables hemoglobin, hematocrit and ferritin between normotensive patients and essential hypertensive and hypotensive? Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 311, 2007. Summary
LE Medina, W Uribe, J Marín, E Gonzalez, G Montero, D Bravo, MA Restrepo, M Jimenez, D Aristizabal, M Duque. Cardiology and autonomic nervous system department. Clínica Medellín, Medellín, Colombia. The importance of arterial hypotension in the chronic fatigue syndrome. Second joint meeting of the European Federation of Autonomic Societies and the American Autonomic Society. Palais Ferstel. Vienna, Austria. October 10-13, 2007. Clinical Autonomic Research. Vol 17, number 5, page 318, 2007. Summary.
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Medina E, Uribe W, Duque M, Alzate L. Diagnosis of orthostatic intolerance based on blood pressure and heart rate characterization. Could symptoms be enough?. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary
Medina E, Uribe W, Duque M, Alzate L. Initial Medical Complain and Symptoms in Patients with Orthostatic Intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:258. Summary
Medina E, Uribe W, Duque M, Alzate L. Past Medical History in patients with Orthostatic Intolerance. XIth International Symposium on the Autonomic Nervous System, Puerto Rico, 24-30. October 2000. Clin Auton Res 2000, 10:258. Summary.
Medina E, Uribe W, Duque M, Alzate L. Patients with orthostatic Intolerance: are those with syncope different from those without? Is syncope an acceptable endpoint for therapy? XIth International Symposium on the Autonomic Nervous System, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:243. Summary
Medina E, Uribe W, Duque M, Alzate L. Severity of Compromise and level of Limitation in patients with Orthostatic Intolerance. XIth International Symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary
Medina E, Uribe W, Duque M, Alzate L. Syncope characterization in patients with orthostatic intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Clin Auton Res 2000, 10:243. Summary.
Medina E, Uribe W, Duque M, Alzate L. Variation of arterial blood pressure and heart rate during follow up in patients with orthostatic intolerance. XIth International symposium on the autonomic nervous system, Puerto Rico, 24-30 October 2000. Summary.
Medina L, Duque M, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Bernal J, Restrepo MA, Arroyave A, Jaramillo G, Torres Y, Uribe W. Essential hypotension registry: Sympathovagal balance at 24 hours, day and night in ambulatory Holter monitoring according to blood pressure groups in real-life settings. Clinical Autonomic Research. Vol 19, Number 5, page 300, 2009. Summary.
Medina L, Duque M, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Bernal J, Restrepo MA, Arroyave A, Jaramillo G, Torres Y, Uribe W. Syncope diagnosis in patients with not apparent structurally heart disease and components for both: neurally mediated and cardiac origin (mixed syncope): is it a quantitative history score reliable? Clinical Autonomic Research. Vol 19, number 5, page 308, 2009. Summary.
Medina L, Mármol A, Duque M, Ossaba S, Uribe W, Olaya M, Marín J, Torres Y, Velásquez J. The tilt table test protocol: How can be improved? Clinical Autonomic Research. Vol 14, Number 5, 2004, page. 310. October 2000. Summary
Medina L, Olaya M, Duque M, Restrepo F, Uribe W, Marín J, Velásquez J, Torres Y. Fatigue: a clue symptom in chronic orthostatic disorder. How can it be explained? Clinical Autonomic Research. Vol 14, Number 5, 2004, page. 310. October 2000. Summar
Medina L, Uribe W, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Velasquez J, Bernal J, Torres Y, Duque M. Chronotropic incompetence in the head-up tilt testing: a useful diagnostic marker or clinically irrelevant finding? Accepted for publication at the European Heart Journal, 2009 (Summary).
Medina L, Uribe W, Marin J, Gonzalez E, Astudillo V, Aristizabal J, Velasquez J, Bernal J, Torres Y, Duque M. Chronotropic incompetence in the head-up tilt testing: a useful diagnostic marker or clinically irrelevant finding? European Heart Journal, 2009 (Summary).
Medina L. Essential hypotension registry. Cardiovascular Reactivity: A search for the integration of the neuro-cardiovascular relationship and their association with glucose challenge and depression. Clinical Autonomic Research. Vol 19, number 5, page 300, 2009. Summary
Medina L. Essential Hypotension registry: Definition, blood pressure and demographic report. Clinical Autonomic Research. Vol 19, number 5, page 308, 2009. Summary
Medina LE, Duque M, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Uribe W. The essential hypotension registry. Rationale for the blood pressure classification and the importance of the stress response. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary
Medina LE, Duque M, Uribe W, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Torres Y, Marin J. It is glucose metabolism (HOMA and the relation: 2 h postprandial plasma glucose/fasting glucose) different between blood pressure groups? The essential hypotension registry. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary.
Medina LE, Duque M, Uribe W, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Torres Y, Marin J. The essential hypotension registry. Blood pressure at the office and at 24 h ambulatory monitoring is different between groups of essential hypertension, normotension and essential hypotension. Clinical Autonomic Research. Vol 20, number 2, page 139, 2010. Summary.
Medina LE, Duque M, Uribe W. Initial medical complaints in patients with orthostatic intolerance. Clin Auton Res 2000, 10: 258 (Summary).
Medina LE, Marin J, Duque M, Uribe W, Mesa S, Aristizabal J, Velasquez J, Restrepo MA, Miranda A, Bernal J, Torres Y. Vasovagal syncope and their relationship with hypotension: What is the current conception and how it may change if essential hypotensive population emerges. The essential hypotension registry. Clinical Autonomic Research. Vol 21, number 2, page 127, 201. Summary
Medina LE, Ospina J, Lemos MA, Cuartas G, Calle J, Gutierrez M, Torres Y. Essential hypotension registry: Psychometric measurements for anxiety, depression and coping strategies: Hypotension is associated with depression and anxiety. Is there a psycho-biotype? Preliminary Report. Clinical Autonomic Research. Vol 19, number 5, page 296, 2009. Summary
Medina LE, Uribe W, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Duque M. The importance of essential hypotension in syncope. A report of 877 patients. The essential hypotension registry. Clinical. Autonomic Research. Vol 20, number 2, page 140, 2010. Summary
Medina LE, Uribe W, Marin J, Aristizabal J, Velasquez J, Miranda A, Torres Y, Restrepo MA, Duque M. What do patients with classical and initial orthostatic hypotension, without an identifiable cause have to teach us? The essential hypotension registry. Description of the population and the blood pressure measurements. Clinical Autonomic Research. Vol 20, number 2, page 140, 2010. Summary
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Syncope Registry | Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis | Up 100 weeks | |
Other | Tilt table testing (TTT) registry | TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables.
TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities. The relationship between neurally mediated syncope response at the TTT and comorbidities. |
Up to 100 weeks | |
Other | Sinus node function at the electrophysiological study (EPS) | EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group | Up to 100 weeks | |
Other | Score for coronary artery disease | Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy. | Up to 200 weeks | |
Other | Neurally Mediated Syncope: further of the transient lost of consciousness (TLC) | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others. Mortality |
A 7-year prospective study | |
Other | Psychobiotype: relationship between biological and psychological variables | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Psychiatric variables: Big Five Questionary (BFQ) for personality. Modify of the Coping Scale (Scale of modified coping strategies) Zung questionary for depression and anxiety MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary |
Up to 100 weeks | |
Other | The role of high sodium intake in the development of essential hypertension. Comparison between essential hypotension (high sodium intake) vs normotension population (normal or low sodium intake) in the follow-up. | High sodium intake in the diet is recognized as a risk factor for hypertension development.
Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups. This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry. Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups. The results will be adjusted for age, gender and BMI. |
4 years | |
Other | White coat effect in the heart rate or masked bradycardia. | Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary.
There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities. Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible. Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed, Other variables to consider are: Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available. The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones. |
1 year | |
Other | Reversible Bradycardia Mimicking Sinus Node Dysfunction as a Manifestation of Subacute Autonomic Nervous System Dysfunction (ANSD). | Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out.
Variables HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation, Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation. |
2 years | |
Other | Description of the blood pressure hemodynamic profile at a medical office and their prognostic implications. | A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB).
This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis. |
Three years | |
Primary | Relationship between Blood pressure group and comorbidities | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality |
A 7-year prospective study | |
Primary | Relationship between adaptability group and comorbidities | Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others.
Cardiovascular mortality Total mortality |
A 7-year prospective study | |
Primary | Relationship between blood pressure group, adaptability group and comorbidities | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality |
A 7-year prospective study | |
Secondary | Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: HR; PR interval, QRS complex, cQT interval Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge. |
A 7-year prospective study | |
Secondary | Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring. | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge. |
A 7-year prospective study | |
Secondary | For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group | Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension.
Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable. Habits: smoke and drink, exercise Anthropometric variables: Body mass index, waist, hip Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine, Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge. |
A 7-year prospective study | |
Secondary | Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) | Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable.
Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge. |
A 7-year prospective study |
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