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| ID | Type | Description | Link |
|---|---|---|---|
| NIH P50 HD057796 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone - PCOS | Experimental | Women with obesity and polycystic ovary syndrome |
|
| Testosterone - premenopausal women | Experimental | Healthy premenopausal women. |
|
| Continuous positive airway pressure | Experimental | Women and men with obesity and obstructive sleep apnea |
|
| Glucocorticoid | Experimental | Lean and obese healthy women, and obese men |
|
| Estrogen | Experimental | Postmenopausal women |
|
| control | Other | Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate | VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration. | Before and at the end of interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration | VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO). | Before and at the end of the interventions |
| VLDL-TG Plasma Clearance Rate (Means) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Mittendorfer, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22619349 | Result | Wang X, Magkos F, Patterson BW, Reeds DN, Kampelman J, Mittendorfer B. Low-dose dexamethasone administration for 3 weeks favorably affects plasma HDL concentration and composition but does not affect very low-density lipoprotein kinetics. Eur J Endocrinol. 2012 Aug;167(2):217-23. doi: 10.1530/EJE-12-0180. Epub 2012 May 22. | |
| 22252942 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Progesterone - PCOS | Women with obesity and polycystic ovary syndrome Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| FG001 | Progesterone - Postmenopausal Women | Postmenopausal women Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| FG002 | Testosterone - Premenopausal Women | Healthy premenopausal women Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| FG003 | Testosterone - Postmenopausal Women | Postmenopausal women Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| FG004 | Continuous Positive Airway Pressure | Obese women and men with obstructive sleep apnea continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks |
| FG005 | Glucocorticoid | Lean and obese healthy women, and obese men glucocorticoid: Dexamethasone 0.013 mg/kg fat-free mass daily, 21 days |
| FG006 | Estrogen | Postmenopausal women Estrogens: Estrogen treatment (100 ug Estradiol daily) administered 14 days followed by 14 days without treatment. Repeat this cycle 3 times. |
| FG007 | Control | Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits |
| FG008 | Control - Baseline Testing Only | Baseline testing only in pre- and postmenopausal women |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone - Premenopausal Women | Healthy, premenopausal women Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention |
| BG001 | Testosterone - Postmenopausal Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate | VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration. | Not included in final analysis: Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3. VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1. Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1. | Posted | Mean | Standard Deviation | umol/min/L plasma | Before and at the end of interventions |
|
Adverse events were monitored over the following periods; Estrogen = 70 days (consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.); Testosterone = 21 days; continuous positive airway pressure = 6 weeks; Dexamethasone = 21 days; Progesterone = 70 days (consisted of 14 days on, 14 days off, 14 days on, 14 days off and a final 14 days on treatment); Control (no treatment) = 31 to 72 days between testing visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone - Premenopausal Women | Healthy, premenopausal women. Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One subject reported that she had more acne that usual while taking estrogen |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon Smith, PhD | Washington University in St Louis | 314-362-4375 | gsmith@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| D013739 | Testosterone |
| D005938 | Glucocorticoids |
| D045422 | Continuous Positive Airway Pressure |
| D004967 | Estrogens |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| control - baseline testing only | No Intervention | Healthy men and women |
| Progesterone - Postmenopausal women | Experimental | Postmenopausal women |
|
| Testosterone - Postmenopausal women | Experimental | Postmenopausal women |
|
|
|
| testosterone | Drug | Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
|
|
| glucocorticoid | Drug | Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
|
| continuous positive airway pressure | Device | Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention. |
|
| Estrogen | Drug | Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. |
|
|
| Control | Other | No treatment with studies performed 31 to 72 days apart |
|
VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. |
| Before and at the end of the interventions |
| VLDL-TG Plasma Clearance Rate (Medians) | VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. | Before and at the end of the interventions |
| Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis | The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model. The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour. | Before and at the end of the intervention |
| Wang X, Smith GI, Patterson BW, Reeds DN, Kampelman J, Magkos F, Mittendorfer B. Testosterone increases the muscle protein synthesis rate but does not affect very-low-density lipoprotein metabolism in obese premenopausal women. Am J Physiol Endocrinol Metab. 2012 Mar 15;302(6):E740-6. doi: 10.1152/ajpendo.00533.2011. Epub 2012 Jan 17. |
| 24694337 | Result | Smith GI, Reeds DN, Okunade AL, Patterson BW, Mittendorfer B. Systemic delivery of estradiol, but not testosterone or progesterone, alters very low density lipoprotein-triglyceride kinetics in postmenopausal women. J Clin Endocrinol Metab. 2014 Jul;99(7):E1306-10. doi: 10.1210/jc.2013-4470. Epub 2014 Apr 2. |
| 24203065 | Result | Smith GI, Yoshino J, Reeds DN, Bradley D, Burrows RE, Heisey HD, Moseley AC, Mittendorfer B. Testosterone and progesterone, but not estradiol, stimulate muscle protein synthesis in postmenopausal women. J Clin Endocrinol Metab. 2014 Jan;99(1):256-65. doi: 10.1210/jc.2013-2835. Epub 2013 Dec 20. |
| Physician Decision |
|
| Withdrawal by Subject |
|
Postmenopausal women Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| BG002 | Progesterone - PCOS | Women with obesity and polycystic ovary syndrome Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| BG003 | Progesterone - Postmenopausal Women | Postmenopausal women Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| BG004 | Continuous Positive Airway Pressure | Women and men with obesity and obstructive sleep apnea continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks |
| BG005 | Glucocorticoid | Lean and obese healthy women, and obese men Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| BG006 | Estrogen | Postmenopausal women Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. |
| BG007 | Control | Postmenopausal women Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits |
| BG008 | Control - Baseline Testing Only | Healthy men and women Baseline testing only |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Testosterone - Premenopausal Women |
Healthy, premenopausal women. Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| OG001 | Testosterone - Postmenopausal Women | Postmenopausal women Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| OG002 | Progesterone - PCOS | Women with obesity and polycystic ovary syndrome Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| OG003 | Progesterone - Postmenopausal Women | Postmenopausal women Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. |
| OG004 | Continuous Positive Airway Pressure | Women and men with obesity and obstructive sleep apnea Continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks |
| OG005 | Glucocorticoid | Lean and obese healthy women, and obese men Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. |
| OG006 | Estrogen | Postmenopausal women Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. |
| OG007 | Control | Postmenopausal women Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits |
| OG008 | Control - Baseline Testing Only | Healthy men and women Baseline testing only |
|
|
|
| Secondary | Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration | VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO). | Not included in final analysis: Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3. VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1. Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1. | Posted | Mean | Standard Deviation | mmol/L | Before and at the end of the interventions |
|
|
|
|
| Secondary | VLDL-TG Plasma Clearance Rate (Means) | VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. | Not included in final analysis: Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3. VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1. Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1. | Posted | Mean | Standard Deviation | mL/min | Before and at the end of the interventions |
|
|
|
|
| Secondary | VLDL-TG Plasma Clearance Rate (Medians) | VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration. | Not included in final analysis: Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3. VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1. Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1. | Posted | Median | Inter-Quartile Range | mL/min | Before and at the end of the interventions |
|
|
|
|
| Secondary | Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis | The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model. The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour. | Not included in final analysis: Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3. Muscle not obtained = Testosterone - premenopausal women x 1; Progesterone postmenopausal women x 1; CPAP x 3; Glucocorticoid x 6; Control - baseline testing only x 6. | Posted | Mean | Standard Deviation | %/h | Before and at the end of the intervention |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Testosterone - Postmenopausal Women | Postmenopausal women Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Progesterone - PCOS | Women with obesity and polycystic ovary syndrome Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. | 0 | 1 | 0 | 1 | 0 | 3 |
| EG003 | Progesterone - Postmenopausal Women | Postmenopausal women Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG004 | Continuous Positive Airway Pressure | Obese women and men with obstructive sleep apnea Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Glucocorticoid | Lean and obese healthy women, and obese men Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG006 | Estrogen | Postmenopausal women Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | Control | Postmenopausal women Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Control - Baseline Testing Only | Healthy men and women Baseline testing only | 0 | 6 | 0 | 6 | 0 | 6 |
|
| Vaginal discharge | Reproductive system and breast disorders | Non-systematic Assessment | One subject reported that she had a small amount of vaginal discharge while taking estrogen |
|
| Itchiness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | On subject reported her ankles were itchy while on progesterone |
|
| Shaking | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One subject in the progesterone group contacted us saying that she was shaking violently while not on treatment. Unrelated to treatment was probably due to a viral infection. |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | One subject in the progesterone group contacted us saying that she was vomiting while not on treatment. Unrelated to treatment was probably due to a viral infection. |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | One subject in the progesterone group contacted us saying that she had diarrhea while not on treatment. Unrelated to treatment was probably due to a viral infection. |
|
| Broken ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject in Progesterone group broke her ankle while on treatment but unrelated to treatment |
|
Not provided
Not provided
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D045165 | Testosterone Congeners |
| D000305 | Adrenal Cortex Hormones |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
|
|
| After |
|
|
| Other |
| ANCOVA | <0.05 | Other |
| ANCOVA | 0.87 | Other |
| ANCOVA | 0.57 | Other |
|
| After |
|
|
| Other |
| ANCOVA | 0.53 | Other |
| ANCOVA | 0.23 | Other |
|
| After |
|
|
| After |
|
| Other |
| ANOVA | 0.96 | P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA | Other |
| ANOVA | <0.05 | P value is the group by treatment interaction from the ANOVA | Other |
| Tukey test | <0.01 | Other |
| Tukey test | <0.01 | Other |
| Tukey test | >0.10 | Other |
| Tukey test | >0.10 | Other |