search
Back to results

Effects of Weight Loss on Vascular Function in Obese Subjects

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Weight Loss
Sponsored by
Mario Fritsch Neves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Cardiovascular diseases, Sleep Apnea Syndromes, Arterial stiffness, Endothelial dysfunction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Hospital Universitario Pedro ErnestoRecruiting
  • Rio de Janeiro State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Poor Cardiovascular Health

Ideal-intermediate Cardiovascular Health

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pulse wave velocity
Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®

Secondary Outcome Measures

Endothelial function
Microvascular reactivity will be evaluated using the laser system contrast image (LSCI)

Full Information

First Posted
December 9, 2019
Last Updated
December 16, 2019
Sponsor
Mario Fritsch Neves
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT04198519
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mario Fritsch Neves
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss, Cardiovascular diseases, Sleep Apnea Syndromes, Arterial stiffness, Endothelial dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective
Masking
ParticipantOutcomes Assessor
Masking Description
The participants do not know if they are classified as poor or intermediate/ideal cardiovascular health.
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Poor Cardiovascular Health
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ideal-intermediate Cardiovascular Health
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Weight Loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulse wave velocity
Description
Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®
Time Frame
Change in PWV after 16-week dietary intervention
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Microvascular reactivity will be evaluated using the laser system contrast image (LSCI)
Time Frame
Change in endothelial function after 16-week dietary intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario F Neves, MD, PhD
Phone
+55 21 28688005
Email
mariofneves@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle R Cunha, MSc
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samanta S Mattos, MSc
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Pedro Ernesto
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samanta S Mattos, MSc
Phone
+552128688485
Email
samantasmattos@gmail.com
First Name & Middle Initial & Last Name & Degree
Marcia RS Klein, PhD
Facility Name
Rio de Janeiro State University
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario F Neves, MD, PhD
Phone
+552128688485
Email
mariofneves@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Weight Loss on Vascular Function in Obese Subjects

We'll reach out to this number within 24 hrs