Polycystic Ovarian Syndrome (PCOS)PCOS-CPETNCT07869017
Longitudinal Metabolic Assessment in PCOS
A study testing the investigators give inositol for two months. in people with Polycystic Ovarian Syndrome (PCOS), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- the investigators give inositol for two months.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz technical university, school of medicine
Trabzon, Trabzon, 61080
About this study
Official title: Longitudinal Assesment of Metabolic Parameters Using Cardiopulmonary Exercise Testing in Patients With Polycyctic Ovary Syndrome
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.
Read more
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)
- Being tested
- the investigators give inositol for two months.
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| pcos | Other | following this arm Receives: Dietary Supplement: the investigators give inositol for two months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start18 Jan 2026
- Primary completion15 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hidayet şal, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869017
- Sponsor's protocol ID
- 2026-1
- Acronym
- PCOS-CPET
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant-level data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assesment of Metabolic Parameters Using Cardiopulmonary Exercise Testing in Patients With Polycyctic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07869017
- Acronym / sponsor ID
- PCOS-CPET / 2026-1
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| pcos | Other | Dietary Supplement: the investigators give inositol for two months.following this arm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Absence of PCOS.
- Use of medications other than inositol, including oral contraceptives or metformin.
- Regular participation in exercise.
- Musculoskeletal disease.
- Cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the investigators give inositol for two months.the investigators give inositol for two months. and then the investigators assesment metabolism on all patients. | Dietary supplement | pcos |
Primary outcome
Outcome Measure vo2max
Time frame: 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.
Outcome Measure: Change in VO₂max/VO₂peak
Time frame: two months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. No. Individual participant-level data will not be made available to other researchers.
Related trials for Polycystic Ovarian Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the investigators give inositol for two months. in people with Polycystic Ovarian Syndrome (PCOS), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure vo2max (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.