ClinicalTrials.gg
CompletedNCT07869017PCOS-CPETUpdated Oct 9, 2026

Longitudinal Metabolic Assessment in PCOS

An interventional study of the investigators give inositol for two months. in Polycystic Ovarian Syndrome (PCOS), sponsored by Karadeniz Technical University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Karadeniz Technical University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2026, registered Sep 2026).
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovarian Syndrome (PCOS)
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's enrollment of 45 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Karadeniz Technical University is the lead sponsor of 150 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Other
    pcos

    following this arm

    Dietary Supplement: the investigators give inositol for two months.

Interventions

  • Dietary supplementthe investigators give inositol for two months.

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

  2. 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.

    Time frame: two months

07

Study locations

1 site
  • Karadeniz technical university, school of medicine
    Trabzon, Trabzon 61080, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — No. Individual participant-level data will not be made available to other researchers.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Sep 2026, 7 months.

Of 206 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's 7 months is below that.

Counting every sponsor, half of 221 studies reached it within 18 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2026
First posted
Oct 9, 2026
StartActual
Jan 18, 2026
Primary completionActual
Sep 15, 2026
CompletionActual
Sep 30, 2026
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869017
Responsible party
hidayet şal (asisstant professor, Karadeniz Technical University) — Principal investigator
First posted
Oct 9, 2026
Start date
Jan 18, 2026
Primary completion
Sep 15, 2026
Completion
Sep 30, 2026
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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