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NCT07687264

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

Sponsor: University of Zurich

View on ClinicalTrials.gov

Summary

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.

Official title: METabolic FLEXibility in PMOS

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2029-07-30

Last Updated

2026-07-07

Healthy Volunteers

Yes

Conditions

PCOS (Polycystic Ovary Syndrome)Insulinemic Response Overweight (BMI > 25)

Interventions

PROCEDURE

Oral Clucose Tolerance Test (oGTT)

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.

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

Locations (1)

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland