Assessment of Metabolic Changes in Response to Glcuose Intake in Women With Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversity of Zurich

About this trial

Polyendocrine metabolic ovarian syndrome (PMOS), previously known as polycystic ovary syndrome (PCOS), is a common endocrine and metabolic condition affecting women of reproductive age. It is associated with hormonal imbalances, irregular menstrual cycles, elevated androgen levels, and metabolic disturbances such as insulin resistance. These metabolic changes can increase the risk of type 2 diabetes and cardiovascular disease.

Insulin resistance means that the body's cells respond less effectively to insulin, a hormone that regulates blood glucose. This leads to compensatory increases in insulin levels, which can further disrupt hormonal balance and contribute to the clinical features of PMOS.

This study aims to investigate how the bodies of women with PMOS respond dynamically to glucose intake compared with women without PMOS. A standard clinical test, the oral glucose tolerance test (oGTT), will be used. Participants consume a glucose solution, and blood samples are collected before and two hours afterward. This procedure is routinely used in clinical practice.

Women with PMOS will be compared with age- and body mass index (BMI)-matched control participants without PMOS. Blood and urine samples will be analyzed using advanced multi-omics technologies to measure proteins, metabolites, extracellular vesicles, and immune-related signals.

The main objective is to understand how metabolic, hormonal, and immune pathways respond over time to a glucose challenge and whether these responses differ in PMOS. Special attention is given to inter-organ communication and systemic metabolic regulation.

The study includes two visits. The first visit involves health assessments, questionnaires, and body composition measurements. The second visit includes the glucose tolerance test and blood sampling. In total, approximately 100 mL of blood will be collected across both visits.

Participation is voluntary, and participants may withdraw at any time without affecting their medical care. The procedures involve minimal risk and consist of standard clinical methods.

The results of this study may improve understanding of PMOS and contribute to better diagnostic and therapeutic strategies in the future.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18-35 years

Body weight (BMI): between BMI 18.5-39.9 kg/m2

Ability to consent and to provide written informed consent

CG: History of regular MCs (21 to 35 days) 3 months prior to study enrollment

Disqualifiers

Use of systemic hormonal contraceptives within the last 3 months prior to study enrollment. Use of levonorgestrel-releasing intrauterine devices is permitted; all other hormonal contraceptive methods are excluded.

CG: A clinically diagnosed or history of a menstrual disorder (e.g., polycystic ovarian syndrome (PCOS), premenstrual dysphoric disorder (PMDD) or amenorrhea)

A clinically diagnosed mental disorder (e.g. major depression, anxiety disorder)

history of epileptic seizure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Clucose Tolerance Test (oGTT)

    Procedure/Surgery

    After an overnight fasting period (≥8 hours), participants ingest a 75 g oral glucose solution. Venous blood samples are collected at predefined time points (fasting and typically 2 hours post-ingestion) to measure plasma glucose and insulin levels. The test evaluates whole-body glucose tolerance and insulin response under controlled metabolic conditions and is routinely used in clinical and research settings.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PMOS groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Normalized Relative Plasma Metabolite Abundance From Baseline to 2 Hours Post-Glucose Ingestion

Assessment of dynamic changes in circulating metabolites in response to a standardized oral glucose tolerance test (oGTT). Metabolomic profiling includes targeted and untargeted analyses of plasma metabolites involved in glucose metabolism, lipid metabolism, amino acid turnover, and energy homeostasis. Longitudinal changes between fasting state and post-glucose challenge will be compared between PMOS participants and age- and BMI-matched controls. The metabolomic response is used as a central readout of systemic metabolic flexibility.

Time frame
Baseline (fasting, Visit 2) and 2 hours post-glucose ingestion (Visit 2).
2

Change in Normalized Relative Plasma Protein Abundance From Baseline to 2 Hours Post-Glucose Ingestion

Quantification of dynamic changes in circulating plasma proteins in response to oGTT using nanoparticle-enhanced high-resolution proteomics. The analysis focuses on proteins involved in insulin signaling, inflammatory pathways, lipid metabolism, endocrine regulation, and inter-organ communication. Temporal protein abundance changes between fasting and post-glucose states will be assessed to characterize systemic proteomic adaptations and differences in metabolic flexibility between PMOS and controls.

Time frame
Baseline (fasting, Visit 2) and 2 hours post-glucose ingestion (Visit 2).

Secondary outcomes

1

Change in oGTT-Derived Glucose and Insulin Response Indices From Baseline to 2 Hours Post-Glucose Ingestion

Integrated assessment of metabolic flexibility based on conventional oGTT parameters, including glucose and insulin dynamics. Derived indices (e.g., insulin sensitivity proxies, glucose clearance patterns) will be used in combination with clinical chemistry to evaluate systemic metabolic responsiveness.

Time frame
Baseline and 2 hours post-glucose ingestion (Visit 2).
2

Change in Concentration of Plasma Extracellular Vesicles From Baseline to 2 Hours Post-Glucose Ingestion

Assessment of extracellular vesicle concentration in plasma at baseline and 2 hours after oral glucose ingestion. EV abundance will be reported as the number of particles per milliliter of plasma (Particles/mL).

Time frame
Baseline and 2 hours post-glucose ingestion (Visit 2).
3

Change in Median Diameter of Plasma Extracellular Vesicles From Baseline to 2 Hours Post-Glucose Ingestion

Assessment of extracellular vesicle size distribution in plasma at baseline and 2 hours after oral glucose ingestion. EV size will be reported as median vesicle diameter in nanometers (nm).

Time frame
Baseline and 2 hours post-glucose ingestion (Visit 2).
4

Change in Normalized Relative Abundance of Extracellular Vesicle-Associated Proteins From Baseline to 2 Hours Post-Glucose Ingestion

Assessment of extracellular vesicle-associated protein abundance in plasma at baseline and 2 hours after oral glucose ingestion. EV protein cargo will be assessed using proteomic profiling and reported as normalized relative protein abundance values.

Time frame
Baseline and 2 hours post-glucose ingestion (Visit 2).

Other outcomes

Sponsors and contacts

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University of Zurich

Lead sponsor

University Hospital, Bonn

Collaborator

ETH Zurich

Collaborator

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