NCT03841981

Body Fat as Determinant of Female Gonadal Dysfunction

Recruiting now Last updated 12 August 2025

What this trial tests

trial testing Anthropometric and physical examination in Polycystic Ovary Syndrome in 50 participants. Currently enrolling.

Timeline

31 January 2020

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	50
Start date	31 January 2020
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	1 location across Spain

Drugs / interventions tested

• Anthropometric and physical examination
• Indirect calorimetry, accelerometer and seven-day dietary recall
• Biochemical, hormonal and metabolic phenotyping
• Sonographic studies
• 24-hour Ambulatory blood pressure monitoring
• Percutaneous biopsy
• Cardiovascular autonomic function studies
• Oral smear and feces specimen

Conditions studied

• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
• Hypothalamic Amenorrhea — all drugs for Hypothalamic Amenorrhea →

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Who can join

Adults 18 to 40, female only, with Polycystic Ovary Syndrome or Hypothalamic Amenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
   Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2