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

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
|
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No Intervention: Healthy controls no ÓSA
no intervention
|
- 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

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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 |
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

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