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Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02683616
Acronym
FAMOSA
Enrollment
35
Registered
2016-02-17
Start date
2015-04-01
Completion date
2019-12-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Positive Airway Pressure, Fatty Acid Metabolism, Obstructive Sleep Apnea

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.

Interventions

DEVICECPAP

Continuous Positive Airway Pressure in cases of moderate/severe OSA

Sponsors

Faculty Hospital Kralovske Vinohrady
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Glycerol release (lipolysis) in adipose tissueBaseline and 6 monthsChanges in interstitial glycerol concentration in adipose tissue
Palmitate oxidation in skeletal muscleBaseline and 6 monthsChanges in palmitate oxidation in muscle biopsies measured ex vivo

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026