Actively Recruiting
Body Fat as Determinant of Female Gonadal Dysfunction
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-08-12
50
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Body Fat as Determinant of Female Gonadal Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18.5 and 25.0 kg/m2 for Group I and IV
- Ovulatory dysfunction per World Health Organization classification for Group I
- Normal or low gonadotrophin levels (FSH and LH < 10 IU/l) and low estradiol (< 50 pg/ml) for Group I
- Moderate to vigorous physical activity (> 5 hours per week) with low energy availability (< 30 kcal/kg lean mass) for Group I
- Polycystic ovary syndrome (PCOS) phenotypes I, II, and III with hyperandrogenemia for Group II
- PCOS phenotype IV for Group III
- Body mass index between 18.5 and 40.0 kg/m2 for Groups II, III, and V
- Regular menses with normal gonadotropins and estradiol levels during follicular phase for Group IV
- Moderate to vigorous physical activity (> 5 hours per week) with normal energy availability (> 30 kcal/kg lean mass) for Group IV
- No signs or symptoms of hyperandrogenism for Group V
- No or mild intensity physical activity for Group V
- Regular menses for Group V
- Signed informed consent for all groups
You will not qualify if you...
- Use of oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids, opioids) within 6 months before study inclusion
- Current pregnancy or lactation or within 6 months before study inclusion
- Asherman's syndrome or outflow tract disorders
- Current smoking or alcohol intake exceeding 40 g per day
- Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, heart or lung diseases, kidney disease, liver disease, celiac disease, malabsorptive conditions, chronic inflammatory disease, or malignancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Endocrinology and Nutrition
Madrid, Madrid, Spain, 28034
Actively Recruiting
Research Team
A
Alejandra Quintero Tobar
CONTACT
S
Sara de Lope Quiñones
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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