Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity (SYBILA)
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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| Spain | |
| Hospital Universitari de Bellvitge | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| 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:
|
Apnea Insulin Resistance Obesity Obesity, Morbid Sleep Apnea Syndromes Sleep Apnea, Obstructive Metabolic Syndrome X Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013