Effects of Weight Loss on Vascular Function in Obese Subjects

Not Applicable

• Conditions: Obesity
• Interventions: Other: Weight Loss

• Registration Number: NCT04198519
• Lead Sponsor: Mario Fritsch Neves

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.

Study Timeline

• Study Start: 2019-11-21
• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-17
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poor Cardiovascular Health	Weight Loss	Cardiovascular health is said to be ideal by the presence of optimal health behaviors (non-smokers, adequate BMI, physical activity level and healthy eating pattern) and ideal health factors (blood pressure, total cholesterol and blood glucose). Poor cardiovascular health is considered for two or less metrics.
Ideal-intermediate Cardiovascular Health	Weight Loss	Cardiovascular health is said to be ideal by the presence of optimal health behaviors (non-smokers, adequate BMI, physical activity level and healthy eating pattern) and ideal health factors (blood pressure, total cholesterol and blood glucose). Ideal cardiovascular health is considered for those with five or more metrics within this qualification, and intermediate for the presence of three or four metrics.

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity	Change in PWV after 16-week dietary intervention	Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®

Secondary Outcome Measures

Name	Time	Method
Endothelial function	Change in endothelial function after 16-week dietary intervention	Microvascular reactivity will be evaluated using the laser system contrast image (LSCI)

Trial Locations

Locations (2)

Hospital Universitario Pedro Ernesto; 🇧🇷 Rio de Janeiro, Brazil

Rio de Janeiro State University; 🇧🇷 Rio de Janeiro, Brazil