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Completed

NCT Number: NCT02683616

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FN Kralovske Vinohrady

Prague, 10034, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

Continuous Positive Airway Pressure in cases of moderate/severe OSA

Primary outcomes

  1. Glycerol release (lipolysis) in adipose tissue

    Time frame: Baseline and 6 months

    Changes in interstitial glycerol concentration in adipose tissue

  2. Palmitate oxidation in skeletal muscle

    Time frame: Baseline and 6 months

    Changes in palmitate oxidation in muscle biopsies measured ex vivo

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Acronym: FAMOSA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2016
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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