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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 7, 2018
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Glycerol release (lipolysis) in adipose tissue [ Time Frame: Baseline and 6 months ]
    Changes in interstitial glycerol concentration in adipose tissue
  • Palmitate oxidation in skeletal muscle [ Time Frame: Baseline and 6 months ]
    Changes in palmitate oxidation in muscle biopsies measured ex vivo
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Glycerol release (lipolysis) in adipose tissue [ Time Frame: 6 months ]
    Changes in interstitial glycerol concentration in adipose tissue
  • Palmitate oxidation in skeletal muscle [ Time Frame: 6 months ]
    Changes in palmitate oxidation in muscle biopsies measured ex vivo
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Official Title  ICMJE Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Fatty Acid Metabolism
  • Continuous Positive Airway Pressure
Intervention  ICMJE Device: CPAP
Continuous Positive Airway Pressure in cases of moderate/severe OSA
Study Arms  ICMJE
  • Experimental: OSA + T2DM
    CPAP treatment
    Intervention: Device: CPAP
  • Experimental: OSA no T2DM
    CPAP treatment
    Intervention: Device: CPAP
  • No Intervention: T2DM no OSA
    Standard care
  • No Intervention: Healthy controls no ÓSA
    no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02683616
Other Study ID Numbers  ICMJE AZV15_30155A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jan Polak, Faculty Hospital Kralovske Vinohrady
Study Sponsor  ICMJE Faculty Hospital Kralovske Vinohrady
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Faculty Hospital Kralovske Vinohrady
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP