Clinical trial NCT04198519: Effects of Weight Loss on Vascular Function in Obese Subjects
Official title: Effects of Weight Loss on Vascular Function in Obese Individuals With Poor Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Cardiovascular diseases
Sleep Apnea Syndromes
Arterial stiffness
Endothelial dysfunction
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of weight loss on vascular function in obese with poor cardiovascular health. The investigators will evaluate the effects of weight loss on total and central body adiposity, blood pressure, central hemodynamic parameters, arterial stiffness, endothelial function, apnea-hypopnea index, insulin resistance and inflammatory markers.

Detailed description: Excessive adipose tissue is associated with adverse metabolic effects and is an important risk factor for chronic diseases. According to the American Heart Association, most cardiovascular events can be prevented by adhering to healthy practices, reflecting cardiovascular health as poor, intermediate, and ideal. Methods: Both sexes, aged between 40 and 70 years, with body mass index ≥ 30 and \< 40 kg/m² will be included and clinical, anthropometric, body composition and laboratory tests will be assessed. In vascular tests, the investigators will evaluate the sympathetic tone using a frequency meter (Polar® RS800), oscillometric pulse wave analysis by Mobil-O-Grah®, post-occlusive microvascular reactivity and carotid ultrasound to measure intimamedia thickness. In the sleep study, the investigators will analyze the presence and degree of obstructive sleep apnea (OSA) through the home polysomnography device (WatchPAT 200®). The first visit will be for screening, clinical and anthropometric evaluation. On the second visit, the vascular tests, instructions and device delivery for sleep study will be performed. Patients will return the following day to return the WatchPAT and to receive the hypocaloric nutritional intervention (800kcal reduction of daily total energy value), which should be followed for 16 weeks. Eight weeks after the beginning of the nutritional intervention a new visit will be scheduled for clinical, nutritional assessment and dietary adjustment. After completing 16 weeks, the patients will return for clinical, laboratory, nutritional, vascular and sleep tests.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes;
* Age between 40 and 70 years;
* Body mass index (BMI) ≥ 30 kg/m² and \<40 kg/m².

Exclusion Criteria:

* Systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg;
* Diabetes mellitus; Hormone replacement therapy;
* Evidence of secondary hypertension;
* Clinically evident changes in thyroid function;
* Acute or chronic kidney or liver disease;
* History of cancer in the last 5 years;
* Clinically evident coronary disease with a history of acute myocardial infarction and/or myocardial revascularization, clinical signs of heart failure, cardiac arrhythmia or clinically significant valve disease;
* Previous stroke;

Primary outcomes:
measure: Pulse wave velocity
timeFrame: Change in PWV after 16-week dietary intervention
Secondary outcomes:
measure: Endothelial function
timeFrame: Change in endothelial function after 16-week dietary intervention
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro State University
Study officials:
affiliation: Rio de Janeiro State University
name: Michelle R Cunha, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rio de Janeiro State University
name: Samanta S Mattos, MSc
role: PRINCIPAL_INVESTIGATOR
References: