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RECRUITINGOBSERVATIONAL

Body Fat as Determinant of Female Gonadal Dysfunction

Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be: Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle. Secondary objectives: 1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution. 2. To study body composition and body fat distribution in these women and their relationships with: 2.1, Sex steroid profiles. 2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure. 2.3 Markers of low-grade chronic inflammation. 2.4. Oxidative stress markers. 2.5. Cardiovascular autonomic function. 2.6. Surrogate markers of subclinical atherosclerosis. 2.7. Circulating concentrations of endocrine disruptors. 2.8. Oral and gut microbiome. The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

Who May Be Eligible (Plain English)

Inclusion Criteria Group I - Body mass index between 18.5 and 25.0 kg/m2. - Group 1 ovulatory dysfunction \[World Health Organization (WHO) classification\]. - Normal/low gonadotrophin levels \[follicle-stimulating hormone (FSH) and luteinizing (LH) \< 10 IU/l\] and low estradiol (\< 50 pg/ml). - Moderate-vigorous intensity physical activity (\> 5 hours per week) plus low energy availability (\< 30 kcal/per kg of lean mass). - Exclusion of secondary etiologies - willing to sign a consent form signed. Group II: - Polycystic ovary syndrome phenotype I, II and III \[National Institute of Health (NIH)-2012\] with hyperandrogenemia (http://prevention.nih.gov/workshops/2012/resources.aspx). - Body mass index between 18.5 and 40.0 kg/m2. - willing to sign a consent form signed. Group III: - Polycystic ovary syndrome phenotype IV (NIH-2012) (http://prevention.nih.gov/workshops/2012/resources.aspx). - Body mass index between 18.5 and 40.0 kg/m2. - willing to sign a consent form signed. Group IV: - Body mass index between 18.5 and 25.0 kg/m2. - Regular menses. - Normal gonadotropins and estradiol levels at follicular phase. - Moderate-vigorous intensity physical activity (\> 5 hours per week) with normal energy availability (\> 30 kcal/per kg of lean mass). - willing to sign a consent form signed. Group V: - No signs or symptoms of hyperandrogenism. - No exercise or mild intensity physical activity. - Regular menses. - Body mass index between 18.5 and 40.0 kg/m2. - willing to sign a consent form signed. Exclusion Criteria (Groups I-V) - Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and/or opioids) for the previous 6 months to study inclusion. - Current pregnancy or lactation, or during the previous 6 months to study inclusion. - Asherman's syndrome or outflow tract disorders. - Current smoking or alcohol intake \> 40 g per day. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria Group I * Body mass index between 18.5 and 25.0 kg/m2. * Group 1 ovulatory dysfunction \[World Health Organization (WHO) classification\]. * Normal/low gonadotrophin levels \[follicle-stimulating hormone (FSH) and luteinizing (LH) \< 10 IU/l\] and low estradiol (\< 50 pg/ml). * Moderate-vigorous intensity physical activity (\> 5 hours per week) plus low energy availability (\< 30 kcal/per kg of lean mass). * Exclusion of secondary etiologies * Informed consent signed. Group II: * Polycystic ovary syndrome phenotype I, II and III \[National Institute of Health (NIH)-2012\] with hyperandrogenemia (http://prevention.nih.gov/workshops/2012/resources.aspx). * Body mass index between 18.5 and 40.0 kg/m2. * Informed consent signed. Group III: * Polycystic ovary syndrome phenotype IV (NIH-2012) (http://prevention.nih.gov/workshops/2012/resources.aspx). * Body mass index between 18.5 and 40.0 kg/m2. * Informed consent signed. Group IV: * Body mass index between 18.5 and 25.0 kg/m2. * Regular menses. * Normal gonadotropins and estradiol levels at follicular phase. * Moderate-vigorous intensity physical activity (\> 5 hours per week) with normal energy availability (\> 30 kcal/per kg of lean mass). * Informed consent signed. Group V: * No signs or symptoms of hyperandrogenism. * No exercise or mild intensity physical activity. * Regular menses. * Body mass index between 18.5 and 40.0 kg/m2. * Informed consent signed. Exclusion Criteria (Groups I-V) * Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and/or opioids) for the previous 6 months to study inclusion. * Current pregnancy or lactation, or during the previous 6 months to study inclusion. * Asherman's syndrome or outflow tract disorders. * Current smoking or alcohol intake \> 40 g per day. * Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.

Treatments Being Tested

DIAGNOSTIC_TEST

Anthropometric and physical examination

* Weight and height. * Waist-to-hip ratio. * Body composition: Bioelectrical impedance and \[Dual energy X-ray absorptiometry (DEXA)\].

DIAGNOSTIC_TEST

Indirect calorimetry, accelerometer and seven-day dietary recall

Energy availability assessment.

DIAGNOSTIC_TEST

Biochemical, hormonal and metabolic phenotyping

* Lipid profile. * Oral glucose tolerance test: plasma glucose and insulin, insulin sensitivity indices, gastrointestinal hormones, adipokines, oxidative stress markers. * Sex steroid profile. * Hypothalamic-pituitary-adrenal axis study. * Ferrokinetic study. * Subclinical chronic inflammatory markers.

DIAGNOSTIC_TEST

Sonographic studies

* Polycystic ovarian morphology. * Carotid intima-media thickness. * Eco-FAT: Ultrasound measurements of adipose tissue depots including sc, preperitoneal, intraperitoneal (ip), mesenteric, and perirenal fat thickness.

DIAGNOSTIC_TEST

24-hour Ambulatory blood pressure monitoring

A\&D TM2430EX oscillometric devices (A\&D Company Limited, Tokyo, Japan).

PROCEDURE

Percutaneous biopsy

Subcutaneous fat tissue and muscle tissue for proteomics an gene expression studies.

DIAGNOSTIC_TEST

Cardiovascular autonomic function studies

Parasympathetic and sympathetic responses to deep breathing, Valsalva's maneuver and orthostatism.

DIAGNOSTIC_TEST

Oral smear and feces specimen

Microbiome studies.

Locations (1)

Endocrinology and Nutrition
Madrid, Madrid, Spain