Sex Steroids, Sleep, and Metabolic Dysfunction in Women - NCT00805207-63110 (Clinical Trial 258472)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy258472.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
St. Louis |
|
State:
|
|
MO |
| Zip Code: |
|
63110 |
| Conditions: |
|
Polycystic Ovary Syndrome - Obstructive Sleep Apnea - Obesity |
| Purpose: |
|
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 and sleep disordered breathing. PCOS affects 5-8%
of women. Sleep disordered breathing affects up to 10% of women. Obstructive sleep apnea
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 TG concentration
associated with obesity, and the effects of polycystic ovary syndrome and obstructive sleep
apnea 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
triglyceride concentration in obese women with polycystic ovary syndrome and obstructive
sleep apnea. 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.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Women aged 18-75 years and men 45-75 years
- Healthy lean and obese women (BMI 18.5-25 kg/m2 and 30-40 kg/m2) and obese men (BMI
30-40 kg/m2)
- Obese women (BMI 30-40 kg/m2) with OSA or PCOS
Exclusion Criteria:
- Pregnant, lactating, peri- or postmenopausal women will be excluded from the study
because of potential confounding influences of these factors and potential ethical
concerns (pregnant women)
- Women taking medications known to affect substrate metabolism and those with evidence
of significant organ dysfunction (e.g. impaired glucose tolerance, diabetes mellitus,
liver disease, hypo- or hyper-thyroidism) other than PCOS and OSA
- Severe hypertriglyceridemia (fasting plasma TG concentration >400 mg/dl)
- Subjects with OSA who have an apnea-hypopnea index (AHI) score >30 (the total number
of obstructive events divided by the total hours of sleep) will be excluded and
instructed to seek medical care |
|
|
|
| Study is available at: |
|
Washington University School of Medicine
St. Louis, MO 63110
United States
Primary Contact:
Wang, PhD
Email: xwang@dom.wustl.edu
Phone: 314-362-8203 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
February 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|