RecruitingNCT03841981

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


Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Enrollment

50 participants

Start Date

Jan 31, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how body fat percentage and exercise-related energy balance affect hormone levels and menstrual function in women, particularly looking at athletes with irregular periods, women with polycystic ovary syndrome (PCOS), and healthy women for comparison. **You may be eligible if...** - You are a woman with irregular or absent periods caused by intense exercise and low calorie intake (relative energy deficiency), OR - You have been diagnosed with polycystic ovary syndrome (PCOS) with high androgen levels, OR - You have a PCOS variant without elevated androgens, OR - You are a healthy woman with regular periods who exercises regularly (as a comparison group) - Your BMI falls within the specified range for your group (between 18.5 and 40) **You may NOT be eligible if...** - You have a secondary cause of menstrual problems that has not been ruled out - You do not meet the specific criteria for any of the four study groups - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTAnthropometric and physical examination

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

DIAGNOSTIC_TESTIndirect calorimetry, accelerometer and seven-day dietary recall

Energy availability assessment.

DIAGNOSTIC_TESTBiochemical, 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_TESTSonographic 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_TEST24-hour Ambulatory blood pressure monitoring

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

PROCEDUREPercutaneous biopsy

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

DIAGNOSTIC_TESTCardiovascular autonomic function studies

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

DIAGNOSTIC_TESTOral smear and feces specimen

Microbiome studies.


Locations(1)

Endocrinology and Nutrition

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03841981


Related Trials