Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203996
Status:
TERMINATED
Last Update Posted:
2023-03-21
First Post:
2005-09-13
Brief Title:
Polycystic Ovary Syndrome PCOS and Sleep Apnea
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Sleep Metabolic and Cardiovascular Dysfunction in Polycystic Ovary Syndrome
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not meet target patient accrual goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic ovary syndrome PCOS affects 5-10 of women in the United States Its onset is usually at the time of puberty with manifestations of menstrual irregularity hirsutism and obesity Women with PCOS suffer at an early stage of adulthood from all of the components of the metabolic syndrome a syndrome that typically has its peak in mid-life in other subject populations Women with PCOS are more insulin resistant than weight-matched control women and have exceptionally high rates of early-onset impaired glucose tolerance and type 2 diabetes as well as a substantially elevated risk for hypertension dyslipidemia coronary and other vascular diseases While recent evidence indicates that the prevalence of sleep-disordered breathing SDB is 30-40 fold higher in PCOS than in weight-matched control women the possible role of SDB in causing the increased metabolic and cardiovascular risks of PCOS has not been evaluated The overall objective of the proposed study is to analyze the direction of causality between sleep disturbances and markers of the metabolic syndrome in PCOS
Detailed Description:
Polycystic ovary syndrome PCOS affects 5-10 of women and may be viewed as the combination of hyperandrogenism with the classical features of the metabolic syndrome in young women PCOS presents a unique opportunity to dissect the relationship between metabolic and cardiovascular risk and sleep disordered breathing SDB in a population where intrinsic effects of aging have not yet developed Because a relationship between obstructive sleep apnea insulin resistance and elevated testosterone levels has also been observed in men and in women without PCOS insights gained from studies in PCOS will have broad implications
The Specific Aims of the present application are
Specific Aim 1 to test the hypothesis that sleep disturbances are caused by hyperandrogenemia and hyperinsulinemia that characterize PCOS Following a detailed baseline evaluation of sleep hormonal metabolic and cardiovascular parameters women with PCOS will be randomized to an 8-week treatment phase with pioglitazone or depot leuprolide plus estrogenprogestin replacement or placebo Pioglitazone will reduce insulin levels and consequently androgen levels in PCOS We will compare the effects of androgen reduction alone depot leuprolide plus estrogenprogestin to those of insulin plus androgen reduction achieved with pioglitazone Primary comparisons will be the change in sleep parameters from baseline between placebo pioglitazone placebo leuprolideestrogenprogestin pioglitazone leuprolideestrogenprogestin
Specific Aim 2 to test the hypothesis that sleep disturbances cause the hormonal metabolic and cardiovascular alterations seen in women with PCOS PCOS women with SDB and matched control women with SDB will be evaluated at baseline and following 8 weeks of CPAP treatment The primary comparison will be between baseline and post-treatment parameters in PCOS women The secondary comparison will be the post-treatment change from baseline between PCOS and control women to test the hypothesis that for the same degree in improvement in SDB the magnitude of change in metabolic and cardiovascular measures will be greater in PCOS than in controls
Specific Aim 3 to test the hypothesis that in normal young women experimental manipulation of sleep that recapitulates the sleep disturbances characteristic of women with PCOS will result in metabolic hormonal and cardiovascular alterations that are typical of the metabolic syndrome A group of healthy young women will be studied twice using a randomized cross-over design In one study rapid eye movement REM sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed In the other slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed Each study will be preceded by 2 nights of baseline sleep Results were not reported for Aim 3 since no devices or drugs were tested in this aim
The Specific Aims of the present application are
Specific Aim 1 to test the hypothesis that sleep disturbances are caused by hyperandrogenemia and hyperinsulinemia that characterize PCOS Following a detailed baseline evaluation of sleep hormonal metabolic and cardiovascular parameters women with PCOS will be randomized to an 8-week treatment phase with pioglitazone or depot leuprolide plus estrogenprogestin replacement or placebo Pioglitazone will reduce insulin levels and consequently androgen levels in PCOS We will compare the effects of androgen reduction alone depot leuprolide plus estrogenprogestin to those of insulin plus androgen reduction achieved with pioglitazone Primary comparisons will be the change in sleep parameters from baseline between placebo pioglitazone placebo leuprolideestrogenprogestin pioglitazone leuprolideestrogenprogestin
Specific Aim 2 to test the hypothesis that sleep disturbances cause the hormonal metabolic and cardiovascular alterations seen in women with PCOS PCOS women with SDB and matched control women with SDB will be evaluated at baseline and following 8 weeks of CPAP treatment The primary comparison will be between baseline and post-treatment parameters in PCOS women The secondary comparison will be the post-treatment change from baseline between PCOS and control women to test the hypothesis that for the same degree in improvement in SDB the magnitude of change in metabolic and cardiovascular measures will be greater in PCOS than in controls
Specific Aim 3 to test the hypothesis that in normal young women experimental manipulation of sleep that recapitulates the sleep disturbances characteristic of women with PCOS will result in metabolic hormonal and cardiovascular alterations that are typical of the metabolic syndrome A group of healthy young women will be studied twice using a randomized cross-over design In one study rapid eye movement REM sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed In the other slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed Each study will be preceded by 2 nights of baseline sleep Results were not reported for Aim 3 since no devices or drugs were tested in this aim
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075079 | NIH | None | httpsreporternihgovquickSearchR01HL075079 |