Body Fat as Determinant of Female Gonadal Dysfunction

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Polycystic Ovary SyndromeHypothalamic Amenorrhea
Interventions
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.

Trial Locations (1)

28034

RECRUITING

Endocrinology and Nutrition, Madrid

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

collaborator

University of Alcala

OTHER

lead

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER