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NCT Number: NCT07483723

Glucose Profiles in Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Continuous Glucose Monitoring Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Glucose Profile Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Salouël, France

Location status: Recruiting

Location contact

Al-Sallameh Abdallah, Pr

CONTACT

[email protected]

33+3.22.08.83.71

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years at inclusion criteria
  • Patient with polycystic ovary syndrome, defined by the presence of at least 2/3 irregular menstrual cycles, clinical or biological hyperandrogenism, polycystic ovary morphology (pelvic ultrasound) or elevated AMH levels, after the exclusion of other disorders.
  • Agreed to carry the FSL pro
  • Signed informed consent

Exclusion criteria

  • Pregnancy, breast-feeding
  • Differential diagnoses: hyperprolactinemia, dysthyroidism, Cushing's syndrome, congenital adrenal hyperplasia, virilizing tumor (ovarian or adrenal), intake of exogenous androgens
  • Pre-existing diabetes
  • Patient treated within 3 months prior to inclusion/data collection with estrogen-progestin contraception, progestin contraception, antidiabetic drugs, inositol, antiandrogen

Treatment and study plan

Sensor

Device

Free-style-libre pro sensor application for 14 days

AGE reader

Device

Analysis of glycation end products by AGE reader

Primary outcomes

  1. Time in range (TIR)

    Time frame: 14 days

    Time in range (TIR) variation between 4 groups

Secondary outcomes

  1. Time in tight range

    Time frame: 14 days

    Time in tight range (70-140 mg/dl) variation between 4 groups

  2. Time above the range

    Time frame: 14 days

    Time above the range variation in 4 groups

  3. Average glycaemia

    Time frame: 14 days

  4. Glycemic variability

    Time frame: 14 days

  5. Presence of hypoglycaemia

    Time frame: 14 days

    Presence of hypoglycaemia

  6. HbA1C

    Time frame: 14 days

  7. Oral glucose tolerance test data

    Time frame: 14 days

  8. Evaluation of glycation end products by AGE reader

    Time frame: 14 days

  9. Assessment of insulin resistance

    Time frame: 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah Al-Salameh, Pr

CONTACT

[email protected]

33+3.22.08.83.71

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PROGLYSOPK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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