Effects of Weight Loss on Vascular Function in Obese Subjects

  • STATUS
    Recruiting
  • End date
    Nov 20, 2023
  • participants needed
    50
  • sponsor
    Mario Fritsch Neves
Updated on 20 February 2022
insulin
body mass index
insulin resistance
Accepts healthy volunteers

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/m 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.

Details
Condition Obesity
Treatment Weight Loss
Clinical Study IdentifierNCT04198519
SponsorMario Fritsch Neves
Last Modified on20 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients of both sexes
Age between 40 and 70 years
Body mass index (BMI) 30 kg/m and <40 kg/m

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
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