- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05410834
Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome (PCOS-RCE)
The Characterization of Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Individuals with polycystic ovarian syndrome (PCOS) have been reported to be at higher risk of cardiovascular disease when compared to those without PCOS. While differential environmental exposures and genetic morphometries are believed to account in part for the difference, there is growing evidence that cardiometabolic risk factors can accelerate pro-vascular progenitor cell depletion and dysfunction. The cumulative effects that aberrant regenerative cell exhaustion (RCE) have on vessel repair accordingly increases the risk of atherothrombotic events.
PCOS-RCE is an observational, cross-sectional, two-arm study that will evaluate the progenitor cell profiles of peripheral blood samples from 30 individuals (15 with PCOS, 15 without PCOS). The working hypothesis is that individuals with PCOS have innately different progenitor cell profiles that can be further altered by their environment and genotype. The resultant differences in RCE capability will affect the balance between pro-inflammatory and vessel repair functions that, in turn, contribute to the contrasting cardiometabolic risks exhibited between the two study cohorts.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Irene Firoz, MB BCh BAO
- Numéro de téléphone: 6478194929
- E-mail: irene.firoz@mail.utoronto.ca
Sauvegarde des contacts de l'étude
- Nom: Aishwarya Krishnaraj, BScH
- E-mail: aishy.krishnaraj@mail.utoronto.ca
Lieux d'étude
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Ontario
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Newmarket, Ontario, Canada, L3Y 2N1
- Centrum Services Newmarket
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Contact:
- Shakkeela Padanilathu Kunjummar, MD
- Numéro de téléphone: 9058538525
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Contact:
- Christina Austin
- Numéro de téléphone: 9058538525
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Scarborough, Ontario, Canada, M1S 4N6
- Diagnostic Assessment Centre
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Contact:
- Subodh Verma, MD PhD
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Woodbridge, Ontario, Canada, L4L 1A6
- Langstaff Medical Centre
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Contact:
- Kristin Terenzi, MD
- Numéro de téléphone: 9058568086
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Capable and willing to provide informed consent
- Females aged 30 and above
Must meet criteria for one of the following two groups:
- Documented diagnosis of PCOS OR
- Normal and regular menstrual cycles with no known diagnosis of PCOS
Exclusion Criteria:
- Menopause, as defined by 12 months of amenorrhea
- Known causes of irregular menstrual bleeding caused by conditions other than PCOS
- Known secondary causes of ovulatory dysfunction and/or hyperandrogenism
- Current pregnancy, active lactation, or less than 6 months postpartum
- Ongoing treatment with ovulation-inducing medication
- History of hysterectomy and/or bilateral oophorectomy
- Severe congestive heart failure (as defined by New York Heart Association - class IV)
- Any life-threatening disease expected to result in death within the next 2 years
- Any malignancy not considered cured. A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening.
- Known severe liver disease
- Known acquired immunodeficiency syndrome such as HIV
- Current treatment with systemic or oral corticosteroid therapy or other immunosuppressive agents
- Known autoimmune disorder (exception: type 1 diabetes)
- Active infectious disease requiring antibiotic or anti-viral agents
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Individuals with polycystic ovarian syndrome
Individuals with a documented diagnosis of polycystic ovarian syndrome
|
Individuals without polycystic ovarian syndrome
Individuals without a known diagnosis of polycystic ovarian syndrome but with regular menstrual cycles
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Frequency of circulating ALDHhiSSChi granulocytes
Délai: Baseline
|
Difference in the frequency of circulating ALDHhi SSChi granulocytes between women with PCOS versus without PCOS
|
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of circulating ALDHhiSSCmid monocytes
Délai: Baseline
|
Difference in the number of circulating ALDHhi SSCmid monocytes with M1 vs M2 polarization between women with PCOS versus without PCOS
|
Baseline
|
Number of circulating ALDHhiSSClo primitive progenitor cells
Délai: Baseline
|
Difference in the number of circulating ALDHhi SSClo primitive progenitor cells in women with PCOS versus without PCOS
|
Baseline
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: David A Hess, PhD, University of Western Ontario, Canada
Publications et liens utiles
Publications générales
- Rotterdam 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.
- Bajuk Studen K, Pfeifer M. Cardiometabolic risk in polycystic ovary syndrome. Endocr Connect. 2018 Jul;7(7):R238-R251. doi: 10.1530/EC-18-0129. Epub 2018 May 29.
- Capoccia BJ, Robson DL, Levac KD, Maxwell DJ, Hohm SA, Neelamkavil MJ, Bell GI, Xenocostas A, Link DC, Piwnica-Worms D, Nolta JA, Hess DA. Revascularization of ischemic limbs after transplantation of human bone marrow cells with high aldehyde dehydrogenase activity. Blood. 2009 May 21;113(21):5340-51. doi: 10.1182/blood-2008-04-154567. Epub 2009 Mar 26.
- Putman DM, Liu KY, Broughton HC, Bell GI, Hess DA. Umbilical cord blood-derived aldehyde dehydrogenase-expressing progenitor cells promote recovery from acute ischemic injury. Stem Cells. 2012 Oct;30(10):2248-60. doi: 10.1002/stem.1206.
- Terenzi DC, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Circulating Pro-Vascular Progenitor Cell Depletion During Type 2 Diabetes: Translational Insights Into the Prevention of Ischemic Complications in Diabetes. JACC Basic Transl Sci. 2018 Nov 5;4(1):98-112. doi: 10.1016/j.jacbts.2018.10.005. eCollection 2019 Feb.
- Hess DA, Terenzi DC, Trac JZ, Quan A, Mason T, Al-Omran M, Bhatt DL, Dhingra N, Rotstein OD, Leiter LA, Zinman B, Sabongui S, Yan AT, Teoh H, Mazer CD, Connelly KA, Verma S. SGLT2 Inhibition with Empagliflozin Increases Circulating Provascular Progenitor Cells in People with Type 2 Diabetes Mellitus. Cell Metab. 2019 Oct 1;30(4):609-613. doi: 10.1016/j.cmet.2019.08.015. Epub 2019 Aug 30.
- Balber AE. Concise review: aldehyde dehydrogenase bright stem and progenitor cell populations from normal tissues: characteristics, activities, and emerging uses in regenerative medicine. Stem Cells. 2011 Apr;29(4):570-5. doi: 10.1002/stem.613.
- Murri M, Luque-Ramirez M, Insenser M, Ojeda-Ojeda M, Escobar-Morreale HF. Circulating markers of oxidative stress and polycystic ovary syndrome (PCOS): a systematic review and meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):268-88. doi: 10.1093/humupd/dms059. Epub 2013 Jan 9.
- Qadura M, Terenzi DC, Verma S, Al-Omran M, Hess DA. Concise Review: Cell Therapy for Critical Limb Ischemia: An Integrated Review of Preclinical and Clinical Studies. Stem Cells. 2018 Feb;36(2):161-171. doi: 10.1002/stem.2751. Epub 2018 Jan 3.
- Hess DA, Wirthlin L, Craft TP, Herrbrich PE, Hohm SA, Lahey R, Eades WC, Creer MH, Nolta JA. Selection based on CD133 and high aldehyde dehydrogenase activity isolates long-term reconstituting human hematopoietic stem cells. Blood. 2006 Mar 1;107(5):2162-9. doi: 10.1182/blood-2005-06-2284. Epub 2005 Nov 3.
- Putman DM, Cooper TT, Sherman SE, Seneviratne AK, Hewitt M, Bell GI, Hess DA. Expansion of Umbilical Cord Blood Aldehyde Dehydrogenase Expressing Cells Generates Myeloid Progenitor Cells that Stimulate Limb Revascularization. Stem Cells Transl Med. 2017 Jul;6(7):1607-1619. doi: 10.1002/sctm.16-0472. Epub 2017 Jun 15.
- Terenzi DC, Trac JZ, Teoh H, Gerstein HC, Bhatt DL, Al-Omran M, Verma S, Hess DA. Vascular Regenerative Cell Exhaustion in Diabetes: Translational Opportunities to Mitigate Cardiometabolic Risk. Trends Mol Med. 2019 Jul;25(7):640-655. doi: 10.1016/j.molmed.2019.03.006. Epub 2019 Apr 30.
- Terenzi DC, Bakbak E, Trac JZ, Al-Omran M, Quan A, Teoh H, Verma S, Hess DA. Isolation and characterization of circulating pro-vascular progenitor cell subsets from human whole blood samples. STAR Protoc. 2021 Feb 1;2(1):100311. doi: 10.1016/j.xpro.2021.100311. eCollection 2021 Mar 19.
- Vassalli G. Aldehyde Dehydrogenases: Not Just Markers, but Functional Regulators of Stem Cells. Stem Cells Int. 2019 Jan 13;2019:3904645. doi: 10.1155/2019/3904645. eCollection 2019.
- Rudnicka E, Suchta K, Grymowicz M, Calik-Ksepka A, Smolarczyk K, Duszewska AM, Smolarczyk R, Meczekalski B. Chronic Low Grade Inflammation in Pathogenesis of PCOS. Int J Mol Sci. 2021 Apr 6;22(7):3789. doi: 10.3390/ijms22073789.
- Xiong YL, Liang XY, Yang X, Li Y, Wei LN. Low-grade chronic inflammation in the peripheral blood and ovaries of women with polycystic ovarian syndrome. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):148-50. doi: 10.1016/j.ejogrb.2011.07.012. Epub 2011 Sep 9.
- Mohammadi M. Oxidative Stress and Polycystic Ovary Syndrome: A Brief Review. Int J Prev Med. 2019 May 17;10:86. doi: 10.4103/ijpvm.IJPVM_576_17. eCollection 2019.
- Aboeldalyl S, James C, Seyam E, Ibrahim EM, Shawki HE, Amer S. The Role of Chronic Inflammation in Polycystic Ovarian Syndrome-A Systematic Review and Meta-Analysis. Int J Mol Sci. 2021 Mar 8;22(5):2734. doi: 10.3390/ijms22052734.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00063366
Plan pour les données individuelles des participants (IPD)
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