Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01029561
• Date of registration: 09/12/2009
• Primary sponsor: Hospital Universitari de Bellvitge
• Public title: Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity SYBILA
• Scientific title: Impact of Obstructive Sleep Apnea Syndrome on Metabolic Syndrome in Severe Obesity
• Date of first enrolment: January 2009
• Target sample size: 126
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01029561
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Carmen Monasterio, MD
• Affiliation: Institut d´Investigació de Bellvitge (IDIBELL)

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adipokines

Cytokines

Insulin Resistance

Metabolic Syndrome

Intervention(s)

Behavioral: Diet

Device: CPAP

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

Beca SEPAR. Num. Ref: 736

PI08/0800

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

August Pi Sunyer Biomedical Research Institute

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Hospital Clinic of Barcelona