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NCT00805207 · ClinicalTrials.gov registry record · NA
Sex Steroids, Sleep, and Metabolic Dysfunction in Women
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
NCT00805207 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 61 participants.
The verdict
NCT00805207, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
Study Summary
Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndrome (PCOS) and sleep disordered breathing. PCOS affects 5-8% of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea (OSA) is the most common cause for sleep disordered breathing and particularly prevalent in obese women with PCOS (\~50%). Both PCOS and OSA augment the increase in plasma triglyceride (TG) concentration associated with obesity, and the effects of PCOS and OSA on plasma TG concentration appear to be additive. The mechanisms responsible for the adverse effects on plasma TG metabolism are not known. The primary goal of this project, therefore, is to determine the mechanisms responsible for the increase in plasma TG concentration in obese women with PCOS and OSA. It is our general hypothesis that alterations in the hormonal milieu that are characteristic of these two conditions are, at least in part, responsible for the increase in plasma TG concentration in obese women with the conditions. Furthermore, we hypothesize that the hormonal aberrations characteristic of the two conditions are particularly harmful to obese, compared with lean, women. The effects of PCOS on skeletal muscle protein metabolism are also not known. However, sex hormones are thought to be important regulators of muscle protein turnover suggesting that muscle protein metabolism is likely to be affected by PCOS. We will examine this by determining the effect of individual sex hormones on muscle protein metabolism and hypothesize that testosterone administration will stimulate muscle protein metabolism while estrogen and progesterone administration will inhibit muscle protein metabolism.
Interventions
- DRUG Progesterone
- DRUG Estrogen
- DRUG testosterone
- DRUG glucocorticoid
- DEVICE continuous positive airway pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00805207
The ClinicalTrials.gov registry entry for NCT00805207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Progesterone is the first listed.
NCT00805207 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00805207 about?
NCT00805207 is a clinical study titled "Sex Steroids, Sleep, and Metabolic Dysfunction in Women". Increased plasma triglyceride concentration is a common feature of the metabolic abnormalities associated with obesity and a major risk factor for cardiovascular disease. Obesity is a major risk factor for two conditions that appear to be increasing in prevalence in women: the polycystic ovary syndr...
What is the current status of trial NCT00805207?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2007-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00805207?
The interventions under investigation include: Progesterone (DRUG), Estrogen (DRUG), testosterone (DRUG), glucocorticoid (DRUG), continuous positive airway pressure (DEVICE).
Who is sponsoring clinical trial NCT00805207?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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