Dyslipidemia, Obesity, Overweight, Sleep Apnea Syndrome
Conditions
Keywords
Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients
Brief summary
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
Interventions
DRUGPlacebo
Fenofibrate-matching placebo tablet
DRUGFenofibrate
145 mg NanoCrystal tablet
Sponsors
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea * Overweight or obese, with BMI \>= 25 kg/m² and \< 40 kg/m². * Known moderate hypertriglyceridemia, with fasting Triglycerides level \>= 2.0 and \< 6.0 mmol/L within 3 months before the inclusion.
Exclusion criteria
* indication for immediate CPAP * other known endocrine disease, except treated and adequately controlled hypothyroidism * renal failure or plasma creatinine level \>130 µmol/L * current chronic liver disease or ALanine Amino Transferase (ALT)\> 2 times the upper normal limit (UNL) * symptomatic gallbladder disease * known muscular disease or creatine phosphokinase (CK) \> 3 times UNL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Apneas | at one month of treatment | Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts). |
| Desaturations | at one month of treatment | Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment. |
| Sleep Time With Oxygen Saturation Below 90% | at one month of treatment | Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients. |
| Apneas | at one month of treatment | Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment |
| Hypopneas | at one month of treatment | Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment. |
| Index Apnea/Hypopnea | at one month of treatment | Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment. |
| Mixed Apneas | at one month of treatment | Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment. |
| Central Apneas | at one month of treatment | Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment. |
| Index of Apneas | at one month of treatment | Average number of apneas per hour of sleep during one night after one month of treatment. |
| Index of Hypopneas | at one month of treatment | Average number of hypopneas per hour of sleep during one night after one month of treatment. |
Countries
France
Participant flow
Recruitment details
Subjects were recruited and treated in a hospital in Paris between September 2005 and January 2008
Pre-assignment details
In total 34 subjects were randomly allocated to treatment (i.e. Subjects Started). All the subjects received the study drug and completed the study. The study was prematurely terminated because of low recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 16 |
| Fenofibrate Fenofibrate 145 mg | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | Placebo | Fenofibrate | Total |
|---|---|---|---|
| Age Continuous | 55.2 years STANDARD_DEVIATION 6.5 | 55.9 years STANDARD_DEVIATION 5.4 | 55.6 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment France | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / — | 3 / — |
| serious Total, serious adverse events | 0 / — | 1 / — |
Outcome results
Primary
Apneas
Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Apneas | 31.0 Number of apneas |
| Fenofibrate | Apneas | 20.5 Number of apneas |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.199ANCOVA
Primary
Central Apneas
Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Central Apneas | 0.0 Number of central apneas |
| Fenofibrate | Central Apneas | 1.0 Number of central apneas |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.333ANCOVA
Primary
Desaturations
Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Desaturations | 171.0 Number of desaturations |
| Fenofibrate | Desaturations | 130.0 Number of desaturations |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.203ANCOVA
Primary
Hypopneas
Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Hypopneas | 69.5 Number of hypopneas |
| Fenofibrate | Hypopneas | 63.0 Number of hypopneas |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.114ANCOVA
Primary
Index Apnea/Hypopnea
Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Index Apnea/Hypopnea | 22.5 Number per hour of sleep |
| Fenofibrate | Index Apnea/Hypopnea | 17.0 Number per hour of sleep |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.533ANCOVA
Primary
Index of Apneas
Average number of apneas per hour of sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Index of Apneas | 4.0 Number per hour of sleep |
| Fenofibrate | Index of Apneas | 2.5 Number per hour of sleep |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.264ANCOVA
Primary
Index of Hypopneas
Average number of hypopneas per hour of sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Index of Hypopneas | 11.0 Number per hour of sleep |
| Fenofibrate | Index of Hypopneas | 9.5 Number per hour of sleep |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.401ANCOVA
Primary
Mixed Apneas
Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Mixed Apneas | 0.0 Number of mixed apneas |
| Fenofibrate | Mixed Apneas | 1.0 Number of mixed apneas |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.521ANCOVA
Primary
Obstructive Apneas
Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).
Time frame: at one month of treatment
Population: The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Obstructive Apneas | 30.5 Number of obstructive apneas |
| Fenofibrate | Obstructive Apneas | 15.0 Number of obstructive apneas |
Comparison: Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.p-value: 0.048ANCOVA
Primary
Sleep Time With Oxygen Saturation Below 90%
Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.
Time frame: at one month of treatment
Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Sleep Time With Oxygen Saturation Below 90% | 11.5 Percentage of sleep time |
| Fenofibrate | Sleep Time With Oxygen Saturation Below 90% | 3.5 Percentage of sleep time |
Comparison: Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.p-value: 0.007Wilcoxon (Mann-Whitney)