Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

NCT ID: NCT02683616

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-12-01

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.

Conditions

Obstructive Sleep Apnea; Fatty Acid Metabolism; Continuous Positive Airway Pressure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OSA + T2DM

CPAP treatment

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Continuous Positive Airway Pressure in cases of moderate/severe OSA

OSA no T2DM

CPAP treatment

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

Continuous Positive Airway Pressure in cases of moderate/severe OSA

T2DM no OSA

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy controls no ÓSA

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CPAP

Continuous Positive Airway Pressure in cases of moderate/severe OSA

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Polak

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FN Kralovske Vinohrady

Prague, , Czechia

Countries

Czechia

Other Identifiers

AZV15_30155A

Identifier Type: -

Identifier Source: org_study_id