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Effects of Weight Loss on Vascular Function in Obese Subjects

NCT ID: NCT04198519

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2023-11-20

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Obesity Weight loss Cardiovascular diseases Sleep Apnea Syndromes Arterial stiffness Endothelial dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants do not know if they are classified as poor or intermediate/ideal cardiovascular health.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Weight Loss

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Weight Loss

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Mario Fritsch Neves

OTHER

Sponsor Role lead

Responsible Party

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Mario Fritsch Neves

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle R Cunha, MSc

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Samanta S Mattos, MSc

Role: PRINCIPAL_INVESTIGATOR

Rio de Janeiro State University

Locations

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Hospital Universitario Pedro Ernesto

Rio de Janeiro, , Brazil

Site Status RECRUITING

Rio de Janeiro State University

Rio de Janeiro, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mario F Neves, MD, PhD

Role: CONTACT

Phone: +55 21 28688005

Email: [email protected]

Facility Contacts

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Samanta S Mattos, MSc

Role: primary

Mario F Neves, MD, PhD

Role: primary

Other Identifiers

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WL-50

Identifier Type: -

Identifier Source: org_study_id