Effects of Weight Loss on Vascular Function in Obese Subjects

Effects of Weight Loss on Vascular Function in Obese Individuals With Poor Cardiovascular Health

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Weight Loss

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario F Neves, MD, PhD; Phone Number: +55 21 28688005; Email: mariofneves@gmail.com

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Recruiting
    • Rio de Janeiro State University
    • Contact: Mario F Neves, MD, PhD; Phone Number: +552128688485; Email: mariofneves@gmail.com
  • Rio de Janeiro, Brazil, 20551-030
    • Recruiting
    • Hospital Universitário Pedro Ernesto
    • Contact: Samanta S Mattos, MSc; Phone Number: +552128688485; Email: samantasmattos@gmail.com
    • Sub-Investigator: Marcia RS Klein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Poor Cardiovascular Health; 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.	Other: Weight Loss; The total energy value (TEV) of the diet prescribed for each study participant will be determined by subtracting 800 kcal / day from the total daily energy expenditure, which will be based on Dietary Reference Intake (DRI) recommendations. The distribution of macronutrients will be as follows: protein 15 to 20% of TEV, lipids 25 to 30% of TEV and carbohydrates 50 to 60% of TEV.
ACTIVE_COMPARATOR: Ideal-intermediate Cardiovascular Health; 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.	Other: Weight Loss; The total energy value (TEV) of the diet prescribed for each study participant will be determined by subtracting 800 kcal / day from the total daily energy expenditure, which will be based on Dietary Reference Intake (DRI) recommendations. The distribution of macronutrients will be as follows: protein 15 to 20% of TEV, lipids 25 to 30% of TEV and carbohydrates 50 to 60% of TEV.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mario Fritsch Neves
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Michelle R Cunha, MSc, Rio de Janeiro State University; Principal Investigator: Samanta S Mattos, MSc, Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2019
• Primary Completion (ANTICIPATED): November 20, 2023
• Study Completion (ANTICIPATED): November 20, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Obesity; Weight loss; Arterial stiffness; Cardiovascular diseases; Sleep Apnea Syndromes
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: WL-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No