NCT02683616: FAMOSA

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Completed NA Last updated 31 March 2022

What this trial tests

NA trial testing CPAP in Obstructive Sleep Apnea in 35 participants. Completed in 1 December 2019.

Timeline

1 April 2015

Primary endpoint
1 April 2019

1 December 2019

Quick facts

Lead sponsor	Faculty Hospital Kralovske Vinohrady
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 April 2015
Primary completion	1 April 2019
Estimated completion	1 December 2019
Sites	1 location across Czechia

Drugs / interventions tested

• CPAP

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Fatty Acid Metabolism — all drugs for Fatty Acid Metabolism →
• Continuous Positive Airway Pressure — all drugs for Continuous Positive Airway Pressure →

Sponsor

Faculty Hospital Kralovske Vinohrady

Who can join

Adults 18 to 85, any sex, with Obstructive Sleep Apnea or Fatty Acid Metabolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obstructive sleep apnoea increases lipolysis and deteriorates glucose homeostasis in patients with type 2 diabetes mellitus.
   Trinh MD, Plihalova A, Gojda J, Westlake K, et al · · 2021 · cited 14× · PMID 33574418 · DOI 10.1038/s41598-021-83018-1
2. Muscle Lipid Oxidation Is Not Affected by Obstructive Sleep Apnea in Diabetes and Healthy Subjects.
   Lattova Z, Slovakova L, Plihalova A, Gojda J, et al · · 2023 · cited 1× · PMID 36982383 · DOI 10.3390/ijms24065308