NCT04198519

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

4 years

First QC Date

December 9, 2019

Last Update Submit

December 16, 2019

Conditions

Obesity

Keywords

ObesityWeight lossCardiovascular diseasesSleep Apnea SyndromesArterial stiffnessEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Endothelial function

    Change in endothelial function after 16-week dietary intervention

Study Arms (2)

Poor Cardiovascular Health

ACTIVE COMPARATOR

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

Ideal-intermediate Cardiovascular Health

ACTIVE COMPARATOR

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

Interventions

Weight LossOTHER

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 HealthPoor Cardiovascular Health

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes;
  • Age between 40 and 70 years;
  • Body mass index (BMI) ≥ 30 kg/m² and \<40 kg/m².

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551-030, Brazil

RECRUITING

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

ObesityWeight LossCardiovascular DiseasesSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Michelle R Cunha, MSc

    Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

  • Samanta S Mattos, MSc

    Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario F Neves, MD, PhD

CONTACT

+55 21 28688005mariofneves@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participants do not know if they are classified as poor or intermediate/ideal cardiovascular health.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 13, 2019

Study Start

November 21, 2019

Primary Completion

November 20, 2023

Study Completion

November 20, 2023

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)