NCT01029561

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 10, 2009

Status Verified

October 1, 2009

Enrollment Period

2.4 years

First QC Date

December 9, 2009

Last Update Submit

December 9, 2009

Conditions

Metabolic SyndromeInsulin ResistanceAdipokinesCytokines

Keywords

Metabolic syndromeInsulin ResistanceAdipokinesProinflammatory markersObstructive Sleep Apnea SyndromeContinuous Positive Airway PressureObesityBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • To analyze the effect of CPAP treatment on insulin resistance and metabolic syndrome in patients with severe obesity and OSA.

    baseline and after 12 weeks of CPAP

Secondary Outcomes (2)

  • To study the relationship between OSA and metabolic syndrome in a population of severely obese patients who are candidates for bariatric surgery.

    baseline and after 12 weeks of CPAP

  • 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.

    baseline and after 12 weeks of CPAP

Study Arms (2)

CPAP and diet

ACTIVE COMPARATOR

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: CPAPBehavioral: Diet

Diet

ACTIVE COMPARATOR

The diet arm wil receive the Conventional diet treatment that usually receive the patients included in the Bariatric Surgery Program

Behavioral: Diet

Interventions

CPAPDEVICE

Treatment with Continuous Positive Airway Pressure

CPAP and diet
DietBEHAVIORAL

Conventional diet treatment that undergo patients in the Bariatric Surgery Program

CPAP and dietDiet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior treatment with CPAP.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

  • Barcelo A, Morell-Garcia D, Salord N, Esquinas C, Perez G, Perez A, Monasterio C, Gasa M, Fortuna AM, Montserrat JM, Mayos M. A randomized controlled trial: branched-chain amino acid levels and glucose metabolism in patients with obesity and sleep apnea. J Sleep Res. 2017 Dec;26(6):773-781. doi: 10.1111/jsr.12551. Epub 2017 May 17.

    PMID: 28513068DERIVED

  • Salord N, Fortuna AM, Monasterio C, Gasa M, Perez A, Bonsignore MR, Vilarrasa N, Montserrat JM, Mayos M. A Randomized Controlled Trial of Continuous Positive Airway Pressure on Glucose Tolerance in Obese Patients with Obstructive Sleep Apnea. Sleep. 2016 Jan 1;39(1):35-41. doi: 10.5665/sleep.5312.

    PMID: 26350474DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin ResistanceSleep Apnea, ObstructiveObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Carmen Monasterio, MD

    Institut d´Investigació de Bellvitge (IDIBELL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

January 1, 2012

Last Updated

December 10, 2009

Record last verified: 2009-10

Locations

ES(1)