NCT02206126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

June 27, 2014

Last Update Submit

July 30, 2014

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaWeight lossObesitySympathetic activityMetabolic profileEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Apnea/hipopnea index

    16 weeks

Secondary Outcomes (6)

  • Blood pressure

    16 weeks

  • Sympathetic activity

    16 weeks

  • Oxidative stress

    16 weeks

  • Inflammatory biomarkers

    16 weeks

  • Metabolic profile

    16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Energy restriction group

EXPERIMENTAL

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

Behavioral: Energy Restriction

Control group

NO INTERVENTION

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

Interventions

Energy RestrictionBEHAVIORAL

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

Energy restriction group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 20-55 years
  • body mass index (BMI) ≥ 30 kg/m2 and \< 40 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Discipline of Clinical and Experimental Pathophysiology, CLINEX

Rio de Janeiro, Rio de Janeiro, 20.551-030, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveWeight LossObesity

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Antonio Felipe Sanjuliani, Dr.

    Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Antonio Felipe Sanjuliani

Study Record Dates

First Submitted

June 27, 2014

First Posted

August 1, 2014

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 1, 2014

Record last verified: 2014-07

Locations

BR(1)