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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy restriction group | Experimental | The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day). |
|
| Control group | No Intervention | The control group was advised not to change their food intake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Restriction | Behavioral | The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea/hipopnea index | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 16 weeks | |
| Sympathetic activity | Plasma levels of catecholamines | 16 weeks |
| Oxidative stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Felipe Sanjuliani, Dr. | Rio de Janeiro State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discipline of Clinical and Experimental Pathophysiology, CLINEX | Rio de Janeiro | Rio de Janeiro | 20.551-030 | Brazil |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |