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Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity (SYBILA)

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ClinicalTrials.gov Identifier: NCT01029561
Recruitment Status : Unknown
Verified October 2009 by Hospital Universitari de Bellvitge.
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2009
Last Update Posted : December 10, 2009
Information provided by:

Study Description
Brief Summary:

The aim of this project is to study the relationship between obstructive sleep apnea (OSA) and metabolic syndrome (MS) in a population of obese patients who are candidates for bariatric surgery. The investigators will study the influence of OSA through hypoxia and sleep fragmentation on different proinflammatory adipokines and cytokines, on metabolic syndrome and on insulin resistance, as well as how these respond to treatment with continuous positive airway pressure (CPAP).

In the first part of the study (part A) the investigators will perform an observational study of cases and controls. Based on the diagnostic polysomnography the patients will be divided into two groups depending on their apnea-hypopnea index (AHI): OSA (AHI >= 15/h) and non-OSA (AHI <15/h). The results will be analyzed depending on the presence or not of OSA.

In the second part of the study (part B), the patients with severe OSA (AHI ≥ 30/h) will be randomized into two groups: one group will receive CPAP + diet treatment and the other group will only receive diet treatment. After 3 months of treatment (CPAP + diet vs. diet), the investigators will analyze the overall effect on metabolic syndrome and the effect on its individual components, as well as the above-mentioned inflammatory pathways and insulin sensitivity, between the 2 groups. This will be carried out through a randomized controlled study in which the investigators will compare the effect of CPAP with the effect of conservative treatment.

Condition or disease Intervention/treatment
Metabolic Syndrome Insulin Resistance Adipokines Cytokines Device: CPAP Behavioral: Diet

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity
Study Start Date : January 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : January 2012

Arms and Interventions

Arm Intervention/treatment
Active Comparator: CPAP and diet
The patients with severe OSA (AHI>=30) who do not fulfill the specific exclusion criteria wil be randomized. In the CPAP and diet arm, patients wil receive Continuous Positive air pressure therapy and the regular dietary treatment.
Device: CPAP
Treatment with Continuous Positive Airway Pressure
Behavioral: Diet
Conventional diet treatment that undergo patients in the Bariatric Surgery Program
Active Comparator: Diet
The diet arm wil receive the Conventional diet treatment that usually receive the patients included in the Bariatric Surgery Program
Behavioral: Diet
Conventional diet treatment that undergo patients in the Bariatric Surgery Program

Outcome Measures

Primary Outcome Measures :
  1. To analyze the effect of CPAP treatment on insulin resistance and metabolic syndrome in patients with severe obesity and OSA. [ Time Frame: baseline and after 12 weeks of CPAP ]

Secondary Outcome Measures :
  1. To study the relationship between OSA and metabolic syndrome in a population of severely obese patients who are candidates for bariatric surgery. [ Time Frame: baseline and after 12 weeks of CPAP ]
  2. To study the influence of OSA on proinflammatory markers and on different adipokines in severely obese patients and their relationship with metabolic syndrome, insulin resistance and body composition. [ Time Frame: baseline and after 12 weeks of CPAP ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria for part A:

Patients who are included in the obesity surgery program will be recruited if they fulfill the following criteria:

  • Age between 18 and 65 years.
  • Body mass index (BMI) >40 kg/m2 or BMI > 35 kg/m2 with co-morbidity related to obesity.

Inclusion Criteria for part B:

In the treatment response study we will include patients diagnosed at the baseline polysomnography with severe OSA (AHI >= 30) who fulfill the inclusion criteria for part A and who do not present specific exclusion criteria for part B.

General Exclusion Criteria (for part A):

  • Prior treatment with CPAP.
  • Severe or unstable cardiovascular disease (severe or surgically treated valvulopathy, myocardial infarction, unstable angina, cardiac surgery) during the 6 months prior to inclusion in the study.
  • Evidence of acute or chronic inflammatory illness different to obesity itself (connective tissue disease, active neoplasia) or associated infectious process during the 6 weeks prior to inclusion in the study.
  • Severe cognitive or psychiatric disorder that would make it difficult to complete the clinical questionnaires.
  • Severe chronic diseases that may interfere in a significant way with the results of the study.
  • Chronic obstructive pulmonary disease defined by FEV1/FVC < 0.7.
  • Pregnancy.
  • Alcohol abuse (daily alcohol consumption >80 g).
  • Express decision of the patient to not participate in the study.

Exclusion Criteria for part B:

  • Severe or incapacitating somnolence.
  • Professional drivers or users of dangerous machinery.
  • Congestive cardiac insufficiency or significant valvulopathy or chronic cor pulmonale.
  • Use of oral anti-diabetic drugs or insulin.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029561

Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
August Pi Sunyer Biomedical Research Institute
Principal Investigator: Carmen Monasterio, MD Institut d´Investigació de Bellvitge (IDIBELL)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carmen Monasterio i Ponsa, Institut d'Investigació Biomèdica de Bellvitge(IDIBELL)
ClinicalTrials.gov Identifier: NCT01029561     History of Changes
Other Study ID Numbers: PI08/0800
Beca SEPAR. Num. Ref: 736 ( Other Grant/Funding Number: SPANISH RESPIRATORY SOCIETY: 736 )
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: December 10, 2009
Last Verified: October 2009

Keywords provided by Hospital Universitari de Bellvitge:
Metabolic syndrome
Insulin Resistance
Proinflammatory markers
Obstructive Sleep Apnea Syndrome
Continuous Positive Airway Pressure
Bariatric surgery

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Metabolic Syndrome X
Sleep Apnea, Obstructive
Insulin Resistance
Obesity, Morbid
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases