Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Obstructive Sleep Apnea Clinical Trial

— FAMOSA  

Official title:

Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683616
• Other study ID #: AZV15_30155A
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2022
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• CPAP
Continuous Positive Airway Pressure in cases of moderate/severe OSA

Locations

Country	Name	City	State
Czechia	FN Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycerol release (lipolysis) in adipose tissue	Changes in interstitial glycerol concentration in adipose tissue	Baseline and 6 months
Primary	Palmitate oxidation in skeletal muscle	Changes in palmitate oxidation in muscle biopsies measured ex vivo	Baseline and 6 months