ObesityNCT04198519
Effects of Weight Loss on Vascular Function in Obese Subjects
A study testing Weight Loss in people with Obesity, run by Mario Fritsch Neves at 2 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 21 Nov 2019to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both sexes;
- Age between 40 and 70 years;
- Body mass index (BMI) ≥ 30 kg/m² and <40 kg/m².
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Universitario Pedro Ernesto
Rio de Janeiro, 20551-030
Samanta S Mattos, MSc, +552128688485, samantasmattos@gmail.com
Marcia RS Klein, PhD
- Recruiting
Rio de Janeiro State University
Rio de Janeiro, 20551-030
Mario F Neves, MD, PhD, +552128688485, mariofneves@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Weight Loss
- Keywords
- Obesity, Weight loss, Cardiovascular diseases, Sleep Apnea Syndromes, Arterial stiffness, Endothelial dysfunction
- Medical subject headings
- Obesity, Weight Loss, Cardiovascular Diseases, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®
Measured: Change in PWV after 16-week dietary intervention
Secondary outcomes (1)
Endothelial function
Microvascular reactivity will be evaluated using the laser system contrast image (LSCI)
Measured: Change in endothelial function after 16-week dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start21 Nov 2019
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Fritsch Neves
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor-investigator, Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
- Investigators
- Michelle R Cunha, MSc, Principal investigator, Rio de Janeiro State UniversitySamanta S Mattos, MSc, Principal investigator, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198519
- Sponsor's protocol ID
- WL-50
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Loss on Vascular Function in Obese Individuals With Poor Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04198519
- Acronym / sponsor ID
- WL-50
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Cardiovascular diseases, Sleep Apnea Syndromes, Arterial stiffness, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mario Fritsch NevesUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Poor Cardiovascular Health | Active comparator | Other: Weight LossCardiovascular 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. |
| Ideal-intermediate Cardiovascular Health | Active comparator | Other: Weight LossCardiovascular 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes;
- Age between 40 and 70 years;
- Body mass index (BMI) ≥ 30 kg/m² and <40 kg/m².
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight LossThe 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. | Other | Ideal-intermediate Cardiovascular Health, Poor Cardiovascular Health |
Primary outcome
Pulse wave velocity
Time frame: Change in PWV after 16-week dietary intervention
Pulse wave velocity (PWV) will be evaluated by oscillometric monitoring system via Mobil-O -Graph®
1 secondary outcome
Endothelial function
Time frame: Change in endothelial function after 16-week dietary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle R Cunha, MSc principal investigator
Rio de Janeiro State University
Samanta S Mattos, MSc principal investigator
Rio de Janeiro State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss in people with Obesity, run by Mario Fritsch Neves at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario F Neves, MD, PhD (+55 21 28688005, mariofneves@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: Change in PWV after 16-week dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.