Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA) (FAMOSA)
Primary Purpose
Obstructive Sleep Apnea, Fatty Acid Metabolism, Continuous Positive Airway Pressure
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
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
Sites / Locations
- FN Kralovske Vinohrady
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
No Intervention
Arm Label
OSA + T2DM
OSA no T2DM
T2DM no OSA
Healthy controls no ÓSA
Arm Description
CPAP treatment
CPAP treatment
Standard care
no intervention
Outcomes
Primary Outcome Measures
Glycerol release (lipolysis) in adipose tissue
Changes in interstitial glycerol concentration in adipose tissue
Palmitate oxidation in skeletal muscle
Changes in palmitate oxidation in muscle biopsies measured ex vivo
Secondary Outcome Measures
Full Information
NCT ID
NCT02683616
First Posted
February 9, 2016
Last Updated
March 17, 2022
Sponsor
Faculty Hospital Kralovske Vinohrady
1. Study Identification
Unique Protocol Identification Number
NCT02683616
Brief Title
Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Acronym
FAMOSA
Official Title
Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Fatty Acid Metabolism, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OSA + T2DM
Arm Type
Experimental
Arm Description
CPAP treatment
Arm Title
OSA no T2DM
Arm Type
Experimental
Arm Description
CPAP treatment
Arm Title
T2DM no OSA
Arm Type
No Intervention
Arm Description
Standard care
Arm Title
Healthy controls no ÓSA
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Continuous Positive Airway Pressure in cases of moderate/severe OSA
Primary Outcome Measure Information:
Title
Glycerol release (lipolysis) in adipose tissue
Description
Changes in interstitial glycerol concentration in adipose tissue
Time Frame
Baseline and 6 months
Title
Palmitate oxidation in skeletal muscle
Description
Changes in palmitate oxidation in muscle biopsies measured ex vivo
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
FN Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
We'll reach out to this number within 24 hrs