Longitudinal Metabolic Assessment in PCOS

NCT07869017 | Completed

• 1 other identifier: 2026-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Outcome Measures

Primary Outcomes (2)

• Outcome Measure vo2max

  Outcome Measure: Change in VO₂max/VO₂peak Time Frame: Baseline to 2 months Description: VO₂max/VO₂peak will be measured during cardiopulmonary exercise testing using the COSMED K5 metabolic system at baseline and after 2 months.

  2 months

• Outcome Measure: Change in VO₂max/VO₂peak

  Time Frame: Baseline to 2 months Description: VO₂max/VO₂peak will be measured during cardiopulmonary exercise testing using the COSMED K5 metabolic system at baseline and after 2 months.

  two months

Study Arms (1)

pcos

OTHER

following this arm

Dietary Supplement: the investigators give inositol for two months.

Interventions

the investigators give inositol for two months. DIETARY_SUPPLEMENT

the investigators give inositol for two months. and then the investigators assesment metabolism on all patients.

pcos

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Absence of PCOS.
• Use of medications other than inositol, including oral contraceptives or metformin.
• Regular participation in exercise.
• Musculoskeletal disease.
• Cardiac disease.
• Systemic diseases, including hypertension.
• Pregnancy.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz technical university, school of medicine

Trabzon, Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be applied. This is a single-arm, prospective observational study in which all participants will undergo the same assessments at baseline and after 2 months. There will be no randomization, control group, or investigator-assigned experimental intervention; therefore, participant, investigator, and outcome-assessor masking will not be applicable.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asisstant professor

Model Details: Intervention Model: Single-group, prospective observational follow-up study. No experimental treatment or intervention will be administered by the investigators. Patients will be followed while receiving inositol treatment initiated as part of routine clinical care, and cardiopulmonary exercise capacity and metabolic parameters will be assessed at baseline and after 2 months.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: January 18, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 30, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)