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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hospital Universitari de Bellvitge.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
August Pi Sunyer Biomedical Research Institute
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01029561
First received: December 9, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention
Metabolic Syndrome
Insulin Resistance
Adipokines
Cytokines
Device: CPAP
Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029561

Locations
Spain
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
Investigators
Principal Investigator: Carmen Monasterio, MD Institut d´Investigació de Bellvitge (IDIBELL)
  More Information

No publications provided

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
Study First Received: December 9, 2009
Last Updated: December 9, 2009
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014