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NCT07869017Completed

Longitudinal Metabolic Assessment in PCOS

Longitudinal Assesment of Metabolic Parameters Using Cardiopulmonary Exercise Testing in Patients With Polycyctic Ovary Syndrome

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

This prospective observational cohort study aims to evaluate longitudinal changes in metabolic status and cardiopulmonary exercise capacity in women with polycystic ovary syndrome (PCOS). Women aged 18-45 years with classic phenotype A PCOS who have initiated inositol treatment will be included. At baseline, participants will undergo cardiopulmonary exercise testing using the COSMED K5 metabolic system, with assessment of VO₂max/VO₂peak and exercise-related metabolic parameters. Body composition, including body fat percentage, fat-free mass, fat mass, and phase angle, will also be assessed using bioelectrical impedance analysis. The same measurements will be repeated after two months to evaluate longitudinal changes. The primary objective is to quantitatively assess the metabolic response of patients with PCOS during clinical follow-up using cardiopulmonary exercise testing. The secondary objective is to characterize temporal changes in metabolic parameters during the treatment period. One-sentence version: This study aims to evaluate longitudinal changes in cardiopulmonary exercise capacity and metabolic parameters in women with classic phenotype PCOS receiving inositol treatment over a two-month follow-up period using COSMED K5 cardiopulmonary exercise testing and bioelectrical impedance analysis.

Status (registry)
Completed
Study type
Interventional
Enrollment
45 (actual)
First submitted
30 Sept 2026
Start date
18 Jan 2026
Primary completion date
15 Sept 2026
Lead sponsor
Karadeniz Technical University
NCT number
NCT07869017

What you commit to

  • Study type: Interventional
  • Participants enrolled: 45
  • From 18 Jan 2026 to the primary completion date, 15 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of medications other than inositol, including oral contraceptives or metformin.

Other illness

  • Musculoskeletal disease.
  • Cardiac disease.
  • Systemic diseases, including hypertension.

Other

  • Absence of PCOS.
  • Regular participation in exercise.
  • Pregnancy.

Who the study is looking for

  • Women aged 18-45 years.
  • Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
  • Classic phenotype (Phenotype A) PCOS, characterized by hyperandrogenism, oligo/anovulation, and polycystic ovarian morphology.
  • Initiation of inositol treatment as part of routine clinical care.
  • Voluntary participation and provision of written informed consent.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Karadeniz technical university, school of medicine
Coordinator of this site? Confirm its status
TrabzonTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.