Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Fatty Acid Metabolism; Continuous Positive Airway Pressure
• Interventions: Device: CPAP

• Registration Number: NCT02683616
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Primary Completion: 2019-04-01
• Study Completion: 2019-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA + T2DM	CPAP	CPAP treatment
OSA no T2DM	CPAP	CPAP treatment

Primary Outcome Measures

Name	Time	Method
Palmitate oxidation in skeletal muscle	Baseline and 6 months	Changes in palmitate oxidation in muscle biopsies measured ex vivo
Glycerol release (lipolysis) in adipose tissue	Baseline and 6 months	Changes in interstitial glycerol concentration in adipose tissue

Trial Locations

Locations (1)

FN Kralovske Vinohrady; 🇨🇿 Prague, Czechia