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A simple blood test may flag hidden insulin problems in PCOS

NCT ID NCT07739953

Diagnosis Sponsor: Guangdong Women and Children Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study looks at whether a protein called ApoC3 in the blood can help identify insulin resistance in women with polycystic ovary syndrome (PCOS), a common cause of infertility and other health issues. Researchers will measure ApoC3 levels in 200 women with PCOS and compare them with standard measures of insulin resistance. The goal is to see if ApoC3 could serve as a quick, reliable biomarker for early screening and better management of PCOS-related complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ApoC3 protein detection kit (blood test)
What this could lead to
If successful, this could lead to a simple blood test to identify insulin resistance in women with PCOS, enabling earlier intervention and better management of related health risks.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The biomarker's accuracy and usefulness in routine practice remain to be validated in larger, more diverse populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study included PCOS patients diagnosed according to the 2003 Rotterdam criteria (at least 2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, or polycystic ovaries on ultrasound). Patients were divided into two groups: PCOS-IR group: met PCOS criteria plus at least one of: HOMA-IR ≥ 2.5, fasting insulin ≥ 15 μIU/mL, or diagnosed IGT/T2DM. PCOS-non-IR group: met PCOS criteria with HOMA-IR \< 2.5 and no glucose metabolism abnormalities. Exclusion criteria: other endocrine disorders, medication use, severe systemic diseases, pregnancy/lactation, or poor sample quality.

Ages

16 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

I. Diagnostic Criteria The 2003 Rotterdam diagnostic criteria for PCOS jointly established by the European Society of Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine (ASRM): Clinical and/or biochemical signs of hyperandrogenism; Oligo-ovulation or anovulation; Ultrasound findings: ovarian volume ≥ 10 mL, and/or \> 12 follicles with a diameter of 2-9 mm in a single section. A diagnosis of PCOS can be established when at least two of the following three criteria are met: ovarian dysfunction, hyperandrogenism, and polycystic ovarian morphology on ultrasound. II. Inclusion and Exclusion Criteria 1. PCOS with Insulin Resistance (PCOS-IR) Inclusion Criteria: Meets the 2003 Rotterdam diagnostic criteria for PCOS (at least 2 of the following 3 items): ① Oligo-ovulation or anovulation; ② Clinical or biochemical signs of hyperandrogenism; ③ Polycystic ovaries on ultrasound (unilateral or ovarian volume ≥ 10 mL). Insulin resistance (IR), meeting at least 1 of the following 3 criteria: ① HOMA-IR ≥ 2.5; ② Fasting insulin ≥ 15 μIU/mL; ③ Diagnosed impaired glucose tolerance (IGT) or type 2 diabetes mellitus (T2DM). Exclusion Criteria: Other endocrine disorders; Medication effects; Severe systemic diseases; Special physiological conditions (e.g., pregnancy, lactation); Poor sample quality. 2. PCOS without Insulin Resistance (PCOS-non-IR) Inclusion Criteria: Meets the PCOS diagnostic criteria (as above), with HOMA-IR \< 2.5 and no glucose metabolism abnormalities. Exclusion Criteria: Same as above.

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PCOS (polycystic ovary syndrome)

Contacts and locations

Locations

  • Guangdong Women and Children Hospital

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.