Weight Loss and Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of moderate energy restriction on the body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress, inflammatory biomarkers, metabolic profile and endothelial function in obese patients with OSA.

Detailed Description
-----------------
Introduction: Nutritional intervention for weight loss is one of the treatment options for obstructive sleep apnea (OSA) in patients with excess body adiposity. However, the effects of moderate energy restriction, recommended by current guidelines for the treatment of obesity, on OSA are not yet known. Objective: To evaluate the effects of moderate energy restriction on the body adiposity; severity of OSA; blood pressure; sympathetic activity; oxidative stress; inflammatory biomarkers; metabolic profile and endothelial function in obese patients with OSA. Methods: A 16-week randomized clinical trial, involving 21 subjects with obesity (grade I or II), aged 20-55 years and presenting an apnea/hipopnea index (AHI) > 5 events/h. Participants were randomized into 2 groups: 11 in the energy restriction group (ERG) and 10 in the control group (CG). The ERG was instructed to follow an energy-restricted diet (-800 kcal/day) and the CG was advised not to change their food intake. At the beginning and at the end of the study, participants underwent evaluation of: OSA with the equipment Watch- PAT200® including the determination of the following parameters of OSA severity: AHI, minimum O2 saturation, number of O2 desaturations >4%; body adiposity (weight, %body fat and circumferences of waist, hip and neck); blood pressure (BP); sympathetic nervous system activity (plasma levels of catecholamines); inflammatory biomarkers (c-reactive protein and adiponectin); oxidative stress (malondialdehyde); metabolism of glucose (glucose, insulin and HOMA-IR) and lipids (total cholesterol and fractions and triglycerides); and endothelial function (index of reactive hyperemia evaluated by Endo - PAT 2000® and cellular adhesion molecules). The statistical analysis was performed with the software STATA v. 10. The level of statistical significance was p < 0.05.

Official Title
-----------------
Effects of Energy Restriction on Sleep Apnea, Sympathetic Activity, Oxidative Stress, Inflammatory Biomarkers, Endothelial Function, Body Adiposity, Metabolic Profile and Blood Pressure in Obese Patients With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Energy Restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 20-55 years body mass index (BMI) ≥ 30 kg/m2 and < 40 kg/m2 Exclusion Criteria: smoking Use of dietary supplements Use of medications that could interfere in body weight, metabolic profile and blood pressure Use of permanent pacemaker; use of α-adrenergic blocking agents Recent changes (within previous 6 months) in body weight (> 3 kg), in dietary intake and in intensity or frequency of physical exercise Diagnosis of diabetes mellitus, hypertension, dyslipidemia (with drug treatment) and kidney disease Clinical history of thyroid dysfunction, angina pectoris, peripheral vascular disease, peripheral neuropathy, heart failure, liver failure, chronic pulmonary disease, gastroesophageal reflux disease, myocardial infarction and stroke; finger deformity that prevents the proper use of the sensors that are necessary to evaluate OSA and endothelial function; and previous bilateral cervical-thoracic sympathectomy Pregnant or lactating women were not allowed into the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy restriction group<br>The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day). | Behavioral: Energy Restriction<br>* The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).<br>|
| No Intervention: Control group<br>The control group was advised not to change their food intake. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea/hipopnea index |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 16 weeks | 
| Sympathetic activity | Plasma levels of catecholamines | 16 weeks | 
| Oxidative stress | Serum levels of malondialdehyde | 16 weeks | 
| Inflammatory biomarkers | Circulating levels of high-sensitivity C reactive protein and adiponectin | 16 weeks | 
| Metabolic profile | Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides | 16 weeks | 
| Endothelial function | Circulating levels of cellular adhesion molecules (intercellular adhesion molecule 1 and P-selectin). Endothelial function was also evaluated by the PAT method, using Endo-PAT 2000®. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, Weight loss, Obesity, Sympathetic activity, Metabolic profile, Endothelial function