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Transcriptional and Epigenetic Program of PCOS Women

NCT04034706 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-03-13

No results posted yet for this study

Summary

The main goal is to reveal differences in global gene expression in two different adipose tissue (AT) depots of females with and without polycystic ovary syndrome (PCOS) and how these are influenced by upstream epigenetic markers

Conditions

  • PCOS

Interventions

OTHER

DEXA

DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner.

OTHER

Magnetic Resonance (MR) Assessment of the Abdomen

Include measures to assess liver lipid content and stiffness and perform volumetric fat quantitation.

OTHER

MR assessment of Whole Body Fat

Volumetric measurement of fat, muscle and bone

PROCEDURE

Adipose tissue biopsy

0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue.

OTHER

Oral glucose tolerance test

Glucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast.

Sponsors & Collaborators

  • AdventHealth Translational Research Institute

    lead OTHER

Principal Investigators

  • Steven Smith, MD · Principal Investigator

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2023-04-12
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034706 on ClinicalTrials.gov