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Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

F

Faculty Hospital Kralovske Vinohrady

Status

Completed

Conditions

Fatty Acid Metabolism
Continuous Positive Airway Pressure
Obstructive Sleep Apnea

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT02683616
AZV15_30155A

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 4 patient groups

OSA + T2DM
Experimental group
Description:
CPAP treatment
Treatment:
Device: CPAP
OSA no T2DM
Experimental group
Description:
CPAP treatment
Treatment:
Device: CPAP
T2DM no OSA
No Intervention group
Description:
Standard care
Healthy controls no ÓSA
No Intervention group
Description:
no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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