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Weight Loss and Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Energy Restriction
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Weight loss, Obesity, Sympathetic activity, Metabolic profile, Endothelial function

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Discipline of Clinical and Experimental Pathophysiology, CLINEX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Energy restriction group

Control group

Arm Description

The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).

The control group was advised not to change their food intake.

Outcomes

Primary Outcome Measures

Apnea/hipopnea index

Secondary Outcome Measures

Blood pressure
Sympathetic activity
Plasma levels of catecholamines
Oxidative stress
Serum levels of malondialdehyde
Inflammatory biomarkers
Circulating levels of high-sensitivity C reactive protein and adiponectin
Metabolic profile
Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides
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®.

Full Information

First Posted
June 27, 2014
Last Updated
July 30, 2014
Sponsor
Rio de Janeiro State University
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1. Study Identification

Unique Protocol Identification Number
NCT02206126
Brief Title
Weight Loss and Obstructive Sleep Apnea
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Weight loss, Obesity, Sympathetic activity, Metabolic profile, Endothelial function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy restriction group
Arm Type
Experimental
Arm Description
The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was advised not to change their food intake.
Intervention Type
Behavioral
Intervention Name(s)
Energy Restriction
Intervention Description
The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
Primary Outcome Measure Information:
Title
Apnea/hipopnea index
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
16 weeks
Title
Sympathetic activity
Description
Plasma levels of catecholamines
Time Frame
16 weeks
Title
Oxidative stress
Description
Serum levels of malondialdehyde
Time Frame
16 weeks
Title
Inflammatory biomarkers
Description
Circulating levels of high-sensitivity C reactive protein and adiponectin
Time Frame
16 weeks
Title
Metabolic profile
Description
Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides
Time Frame
16 weeks
Title
Endothelial function
Description
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®.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Felipe Sanjuliani, Dr.
Organizational Affiliation
Rio de Janeiro State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Discipline of Clinical and Experimental Pathophysiology, CLINEX
City
Rio de Janeiro
ZIP/Postal Code
20.551-030
Country
Brazil

12. IPD Sharing Statement

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Weight Loss and Obstructive Sleep Apnea

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