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Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA) (FAMOSA)

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ClinicalTrials.gov Identifier: NCT02683616
Recruitment Status : Unknown
Verified February 2018 by Jan Polak, Faculty Hospital Kralovske Vinohrady.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jan Polak, Faculty Hospital Kralovske Vinohrady

Study Description
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Brief Summary:
Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the development of glucose intolerance and T2DM. The project is targeting the gap in providing effective treatment of metabolic impairments associated with OSA, particularly T2DM. In contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP treatment, as investigators suggested recently. Clearly, the search for additional treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM development. The aim of the study is to target adipose tissue and muscle dysfunction leading to elevated FFA and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of FFA oxidation.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Fatty Acid Metabolism Continuous Positive Airway Pressure Device: CPAP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: OSA + T2DM
CPAP treatment
 Device: CPAP
Continuous Positive Airway Pressure in cases of moderate/severe OSA
Experimental: OSA no T2DM
CPAP treatment
 Device: CPAP
Continuous Positive Airway Pressure in cases of moderate/severe OSA
No Intervention: T2DM no OSA
Standard care
No Intervention: Healthy controls no ÓSA
no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Glycerol release (lipolysis) in adipose tissue [ Time Frame: Baseline and 6 months ]
    Changes in interstitial glycerol concentration in adipose tissue

  2. Palmitate oxidation in skeletal muscle [ Time Frame: Baseline and 6 months ]
    Changes in palmitate oxidation in muscle biopsies measured ex vivo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 Diabetes mellitus
  • Age 18 - 85 years
  • BMI 22-40 kg/m2
  • moderate or severe OSA diagnosed by home sleep study

Exclusion Criteria:

  • treatment with insulin
  • other acute or chronic endocrine or inflammatory disease
Contacts and Locations
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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): NCT02683616


Contacts
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Contact: Jan Polak, MD, PhD +420267162710 jan.polak@lf3.cuni.cz
Contact: Jan Gojda, MD, PhD +420267168144

Locations
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Czechia
FN Kralovske Vinohrady Recruiting
Prague, Czechia, 10034
Contact: Jan Polak, MD, PhD    +420267162710    jan.polak@lf3.cuni.cz   
Contact: Jan Gojda, MD, PhD    +420267168144    jan.gojda@lf3.cuni.cz   
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
More Information
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Responsible Party: Jan Polak, Associate Professor, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT02683616    
Other Study ID Numbers: AZV15_30155A
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases