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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
Faculty Hospital Kralovske Vinohrady
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 9, 2016
Last Updated
March 17, 2022
Sponsor
Faculty Hospital Kralovske Vinohrady
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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

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Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)

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