Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA) (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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Fatty Acid Metabolism
• Intervention / Treatment: Device: CPAP

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 10034
    • FN Kralovske Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OSA + T2DM; CPAP treatment	Device: CPAP; Continuous Positive Airway Pressure in cases of moderate/severe OSA
Experimental: OSA no T2DM; CPAP treatment	Device: CPAP; Continuous Positive Airway Pressure in cases of moderate/severe OSA
No Intervention: T2DM no OSA; Standard care
No Intervention: Healthy controls no ÓSA; no intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: AZV15_30155A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO