Clinical trial · Interventional
Assessment of Metabolic Changes in Response to Glcuose Intake in Women With Polyendocrine Metabolic Ovarian Syndrome (PMOS)
METabolic FLEXibility in PMOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulinemic Response | — | UNRESOLVED | — |
| Overweight (BMI > 25) | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Clucose Tolerance Test (oGTT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PMOS group
- description
- Woman diagnosed with PMOS, BMI 18.5-39.9 kg/m2
- interventionNames
- Procedure: Oral Clucose Tolerance Test (oGTT)
- type
- EXPERIMENTAL
- label
- Control group
- description
- Control participants will be selected to match PMOS group participants with respect to age (±3 years) and BMI (≤ ±2 kg/m²).
- interventionNames
- Procedure: Oral Clucose Tolerance Test (oGTT)
Primary outcomes (2)
- measure
- Change in Normalized Relative Plasma Metabolite Abundance From Baseline to 2 Hours Post-Glucose Ingestion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDRotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098. PMID 14688154
- BACKGROUNDFerdosi S, Tangeysh B, Brown TR, Everley PA, Figa M, McLean M, Elgierari EM, Zhao X, Garcia VJ, Wang T, Chang MEK, Riedesel K, Chu J, Mahoney M, Xia H, O'Brien ES, Stolarczyk C, Harris D, Platt TL, Ma P, Goldberg M, Langer R, Flory MR, Benz R, Tao W, Cuevas JC, Batzoglou S, Blume JE, Siddiqui A, Hornburg D, Farokhzad OC. Engineered nanoparticles enable deep proteomics studies at scale by leveraging tunable nano-bio interactions. Proc Natl Acad Sci U S A. 2022 Mar 15;119(11):e2106053119. doi: 10.1073/pnas.2106053119. Epub 2022 Mar 11. PMID 35275789
- BACKGROUNDMansournia MA, Jewell NP, Greenland S. Case-control matching: effects, misconceptions, and recommendations. Eur J Epidemiol. 2018 Jan;33(1):5-14. doi: 10.1007/s10654-017-0325-0. Epub 2017 Nov 3. PMID 29101596
- BACKGROUNDTkach M, Thery C. Communication by Extracellular Vesicles: Where We Are and Where We Need to Go. Cell. 2016 Mar 10;164(6):1226-1232. doi: 10.1016/j.cell.2016.01.043. PMID 26967288
- BACKGROUNDChen R, Mias GI, Li-Pook-Than J, Jiang L, Lam HY, Chen R, Miriami E, Karczewski KJ, Hariharan M, Dewey FE, Cheng Y, Clark MJ, Im H, Habegger L, Balasubramanian S, O'Huallachain M, Dudley JT, Hillenmeyer S, Haraksingh R, Sharon D, Euskirchen G, Lacroute P, Bettinger K, Boyle AP, Kasowski M, Grubert F, Seki S, Garcia M, Whirl-Carrillo M, Gallardo M, Blasco MA, Greenberg PL, Snyder P, Klein TE, Altman RB, Butte AJ, Ashley EA, Gerstein M, Nadeau KC, Tang H, Snyder M. Personal omics profiling reveals dynamic molecular and medical phenotypes. Cell. 2012 Mar 16;148(6):1293-307. doi: 10.1016/j.cell.2012.02.009. PMID 22424236
- BACKGROUNDOzer OF, Ibrahimoglu AZ, Gul AZ, Demirel M, Ates S, Taha HS, Ibrahimoglu M, Selek S. Mass spectrometry-based untargeted metabolomics study of polycystic ovary syndrome. J Ovarian Res. 2025 Nov 12;18(1):255. doi: 10.1186/s13048-025-01842-9.