Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07687264

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 35 Years

SexFemale

Healthy volunteersAccepted

ConditionPCOS (Polycystic Ovary Syndrome), Insulinemic Response, Overweight (BMI > 25)

Full registry criteria

Inclusion Criteria: * 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 * PCOS-G: Existing or new established diagnosis of PCOS. Diagnosis is verified in accordance with the ESHRE/ASRM Rotterdam consensus (2003)23, phenotype A (hyperandrogenism, oligo-/anovulation, and polycystic ovarian morphology). PCOS is diagnosed when at least the following three criteria are present, after exclusion of other etiologies: * Oligo- or anovulation * Clinical and/or biochemical signs of hyperandrogenism * Polycystic ovaries on ultrasound (≥12 follicles per ovary measuring 2-9 mm in diameter and/or ovarian volume \>10 mL) Exclusion Criteria: * 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 * history of or current manic or psychotic episode * existing/current eating disorders (bulimia nervosa, anorexia nervosa) within the past 5 years * inability to communicate adequately in speech * inability to follow instructions * regular use of medication other than thyroxine * alcohol consumption as equivalent doses of more than 12 g of pure alcohol per day * vegan diet * daily nicotine consumption * currently or history of (regular) consumption of illegal drugs within the last year * pregnancy or breastfeeding * known diseases of the cardiovascular system * arterial hypertension above 160/90 mm/Hg at rest * known pulmonary diseases * Arthritis and rheumatic diseases and conditions * Hematologic diseases * surgery less than 1 month ago * having given birth within 12 months before the start of the study

Treatments and study arms

Oral Clucose Tolerance Test (oGTT)

Procedure

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.

Primary outcomes

Change in Normalized Relative Plasma Metabolite Abundance From Baseline to 2 Hours Post-Glucose IngestionBaseline (fasting, Visit 2) and 2 hours post-glucose ingestion (Visit 2).

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.

Change in Normalized Relative Plasma Protein Abundance From Baseline to 2 Hours Post-Glucose IngestionBaseline (fasting, Visit 2) and 2 hours post-glucose ingestion (Visit 2).

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.

Study locations

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University Hospital Zurich🇨🇭 Zurich, Canton of Zurich, Switzerland

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Jens Stepan, MD, PhDContact

Email · Call +41 43 253 17 59