Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
FAMOSA
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 31, 2022
March 1, 2022
4 years
February 9, 2016
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
OSA + T2DM
EXPERIMENTALCPAP treatment
OSA no T2DM
EXPERIMENTALCPAP treatment
T2DM no OSA
NO INTERVENTIONStandard care
Healthy controls no ÓSA
NO INTERVENTIONno intervention
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes mellitus
- Age 18 - 85 years
- BMI 22-40 kg/m2
- moderate or severe OSA diagnosed by home sleep study
You may not qualify if:
- treatment with insulin
- other acute or chronic endocrine or inflammatory disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FN Kralovske Vinohrady
Prague, 10034, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 17, 2016
Study Start
April 1, 2015
Primary Completion
April 1, 2019
Study Completion
December 1, 2019
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share