Effects of Weight Loss on Vascular Function in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198519
• Other study ID #: WL-50
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: November 20, 2023

Study information

• Verified date: December 2019
• Source: Hospital Universitario Pedro Ernesto
• Contact: Mario F Neves, MD, PhD
• Phone: +55 21 28688005
• Email: mariofneves[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro
Brazil	Rio de Janeiro State University	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Mario Fritsch Neves	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

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