Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

NCT00696111

Polycystic Ovary Syndrome Obstructive Sleep Apnea

COMPLETED NA

Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

NCT00203996

Polycystic Ovary Syndrome Obstructive Sleep Apnea

TERMINATED PHASE4

Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents

NCT01840618

Obstructive Sleep Apnea Syndrome Polycystic Ovary Syndrome Sleep Apnea

COMPLETED

Restoring Metabolic and Reproductive Health With Sleep in PCOS Study, CPAP Trial

NCT05920694

Polycystic Ovary Syndrome Obstructive Sleep Apnea

ACTIVE_NOT_RECRUITING NA

Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

NCT01421797

Hyperandrogenemia Polycystic Ovary Syndrome Obesity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome (PCOS) Obstructive Sleep Apnea Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progesterone - PCOS

Women with obesity and polycystic ovary syndrome

Group Type EXPERIMENTAL

Progesterone

Intervention Type 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.

Testosterone - premenopausal women

Healthy premenopausal women.

Group Type EXPERIMENTAL

testosterone

Intervention Type 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.

Continuous positive airway pressure

Women and men with obesity and obstructive sleep apnea

Group Type EXPERIMENTAL

continuous positive airway pressure

Intervention Type 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.

Glucocorticoid

Lean and obese healthy women, and obese men

Group Type EXPERIMENTAL

glucocorticoid

Intervention Type 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.

Estrogen

Postmenopausal women

Group Type EXPERIMENTAL

Estrogen

Intervention Type 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

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

Group Type OTHER

Control

Intervention Type OTHER

No treatment with studies performed 31 to 72 days apart

control - baseline testing only

Healthy men and women

Group Type NO_INTERVENTION

No interventions assigned to this group

Progesterone - Postmenopausal women

Postmenopausal women

Group Type EXPERIMENTAL

Progesterone

Intervention Type 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.

Testosterone - Postmenopausal women

Postmenopausal women

Group Type EXPERIMENTAL

testosterone

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Control

No treatment with studies performed 31 to 72 days apart

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endometrin 1% AndroGel Estradiol Patch, Mylan Pharmaceuticals Inc.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes