A nontargeted proteomic approach to the study of visceral and subcutaneous adipose tissue in human obesity.
María Insenser, Rafael Montes-Nieto, Nuria Vilarrasa...
https://pubmed.ncbi.nlm.nih.gov/22796336/Actively Recruiting
Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-08-12
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research investigates how abnormalities in body fat amount, distribution, and function relate to female gonadal dysfunctions, including hypothalamic amenorrhea and polycystic ovary syndrome PCOS. The study aims to better understand how fat tissue communicates with the female reproductive system and to identify new biomarkers that could help diagnose and treat these conditions. Participants include women with different types of PCOS, exercise-related amenorrhea, and healthy controls. Women in five groups will be studied, including those with exercise-associated hypothalamic amenorrhea, hyperandrogenic and non-hyperandrogenic PCOS both lean and with weight excess, women who exercise but have normal ovulation, and healthy women with no regular exercise. Researchers will collect samples and data from fat tissue, muscle, blood, and microbiome to analyze proteins, gene expression, hormones, body composition, cardiovascular health, and inflammatory markers. Participants will undergo detailed physical exams, body composition scans, blood tests, glucose tolerance tests, ultrasound imaging, blood pressure monitoring, biopsies, and microbiome sampling. Researchers will measure adipokine and myokine signals over up to five years and assess their associations with reproductive hormones and cardiovascular risk factors. The study includes comprehensive monitoring of metabolism, inflammation, oxidative stress, and the microbiome to explore their links to reproductive health.
CONDITIONS
Body Fat as Determinant of Female Gonadal Dysfunction
A
Alejandra Quintero Tobar
S
Sara de Lope Quiñones
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead Sponsor
Instituto de Salud Carlos III
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 5 years
Participants undergo various diagnostic assessments including anthropometric and physical examinations, biochemical and hormonal phenotyping, sonographic studies, cardiovascular autonomic function studies, microbiome specimen collection, energy availability assessments, 24-hour ambulatory blood pressure monitoring, and tissue biopsies to study body fat distribution and female gonadal dysfunction.
Initial comprehensive assessment visit with possible follow-up assessments depending on cohort assignment
Duration - Up to 5 years
Participants are monitored over time to investigate associations between body composition, sex steroids, metabolic parameters, cardiovascular function, and other health markers related to female gonadal dysfunction.
Periodic follow-up visits as determined by study protocol
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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https://pubmed.ncbi.nlm.nih.gov/24684164/Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead Sponsor
Instituto de Salud Carlos III
Collaborating Sponsor