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Trial record 5 of 16 for:    "Ovarian Cyst" | "Testosterone"

Sex Steroids, Sleep, and Metabolic Dysfunction in Women (SCOR)

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ClinicalTrials.gov Identifier: NCT00805207
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 5, 2008
First Posted Date  ICMJE December 9, 2008
Results First Submitted Date  ICMJE February 5, 2018
Results First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate [ Time Frame: Before and at the end of interventions ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
VLDL-TG secretion and plasma clearance rates, total plasma TG and VLDL-TG concentrations [ Time Frame: Before and at the end of interventions ]
Change History Complete list of historical versions of study NCT00805207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration [ Time Frame: Before and at the end of the interventions ]
    VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO).
  • VLDL-TG Plasma Clearance Rate (Means) [ Time Frame: Before and at the end of the interventions ]
    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.
  • VLDL-TG Plasma Clearance Rate (Medians) [ Time Frame: Before and at the end of the interventions ]
    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.
  • Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis [ Time Frame: Before and at the end of the intervention ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2008)
VLDL-apoB-100 kinetics and plasma TG, VLDL-TG, VLDL-apoC-II, VLDL-apoC-III, and VLDL-apoE concentrations [ Time Frame: Before and at the end of the interventions ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sex Steroids, Sleep, and Metabolic Dysfunction in Women
Official Title  ICMJE Sex Steroids, Sleep, and Metabolic Dysfunction in Women
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Polycystic Ovary Syndrome (PCOS)
  • Obstructive Sleep Apnea
  • Obesity
Intervention  ICMJE
  • Drug: 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.
    Other Name: Endometrin
  • Drug: 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.
    Other Name: 1% AndroGel
  • Drug: glucocorticoid
    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.
  • Device: continuous positive airway pressure
    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.
  • Drug: Estrogen
    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.
    Other Name: Estradiol Patch, Mylan Pharmaceuticals Inc.
  • Other: Control
    No treatment with studies performed 31 to 72 days apart
Study Arms  ICMJE
  • Experimental: Progesterone - PCOS
    Women with obesity and polycystic ovary syndrome
    Intervention: Drug: Progesterone
  • Experimental: Testosterone - premenopausal women
    Healthy premenopausal women.
    Intervention: Drug: testosterone
  • Experimental: Continuous positive airway pressure
    Women and men with obesity and obstructive sleep apnea
    Intervention: Device: continuous positive airway pressure
  • Experimental: Glucocorticoid
    Lean and obese healthy women, and obese men
    Intervention: Drug: glucocorticoid
  • Experimental: Estrogen
    Postmenopausal women
    Intervention: Drug: Estrogen
  • 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
    Intervention: Other: Control
  • No Intervention: control - baseline testing only
    Healthy men and women
  • Experimental: Progesterone - Postmenopausal women
    Postmenopausal women
    Intervention: Drug: Progesterone
  • Experimental: Testosterone - Postmenopausal women
    Postmenopausal women
    Intervention: Drug: testosterone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2008)
80
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 18-75 years and men 45-75 years
  • Healthy lean, overweight and obese women (BMI 18-40 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805207
Other Study ID Numbers  ICMJE 07-0692
NIH P50 HD057796
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP