NAFLD bei Jugendlichen und jungen Erwachsenen mit PCOS
Nichtalkoholische Fettlebererkrankung (NAFLD), Insulinresistenz und Dyslipidämie bei Jugendlichen und jungen Erwachsenen mit polyzystischem Ovarialsyndrom (PCOS)
This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by studying liver fat deposition measured by magnetic resonance spectroscopy (MRS); 2) To assess the association of percentage liver fat with biomarkers of Non-alcoholic fatty liver disease (NAFLD), dyslipidemia, insulin resistance and body composition in PCOS and controls.
In the proposed study, 40 adolescents and young adults with PCOS and 40 age-comparable control subjects will be evaluated for metabolic disturbances and elevated liver fat using noninvasive and state-of-the-art techniques including MRI, dual-energy x-ray absorptiometry and an oral glucose tolerance test in order to fully assess the metabolic and body composition differences between these groups. This research proposal represents a critical step in understanding the metabolic and cardiovascular comorbidities of PCOS and their relationship to NAFLD. The investigator hopes to use the results generated by this research proposal in order to lay the groundwork for the prevention and treatment of metabolic disorders in adolescents with PCOS. The overarching goal is to decrease and prevent lifelong morbidity associated with this common disorder.
Studienübersicht
Status
Detaillierte Beschreibung
PCOS is a common condition that frequently presents in adolescence and young adulthood and is defined by the presence of hyperandrogenism and ovulatory dysfunction. Affected individuals are at increased risk of insulin resistance, NAFLD and dyslipidemia, which are features associated with the metabolic syndrome, a major public health concern. The associations between PCOS and both insulin resistance and dyslipidemia have been extensively described; however, its association with NAFLD has only recently been noted and superficially studied in adolescents and young adults. Additionally, it has not yet been fully elucidated why seemingly healthy nonobese adolescents with PCOS are predisposed to insulin resistance and its related complications. The susceptibility of certain PCOS patients to developing NAFLD is theorized to be due to the following potentiating factors: insulin resistance, hyperandrogenemia, and a genetic predisposition.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10032
- Columbia University Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Healthy adolescent girls and young women 14 - 25 years with and without PCOS
Beschreibung
Inclusion Criteria:
- All: Healthy; between 14 and 25 years; at least 2 years postmenarche
- PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the NIH 1990 criteria.
- Controls: Regular menses; no clinical hyperandrogenism and/or hyperandrogenemia
Exclusion Criteria:
- Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- History of current or past pregnancy
- Hormonal contraceptive or metformin use within 3 months of enrollment
- Nonclassical congenital adrenal hyperplasia
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_CONTROL
- Zeitperspektiven: CROSS_SECTIONAL
Kohorten und Interventionen
Gruppe / Kohorte |
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PCOS subjects
Forty adolescents and young adults between the ages of 14 and 25 years with Polycystic Ovary Syndrome (PCOS) at least two years past menarche. |
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Control subjects
Forty unaffected adolescents and young adults between the ages of 14 and 25 years at least two years past menarche. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Difference in percentage liver fat between PCOS and controls in adolescents and young adults
Zeitfenster: 1 day
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To compare percentage liver fat by magnetic resonance spectroscopy between adolescents and young adults with PCOS and controls to determine if there is a difference between these groups. |
1 day
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.
Zeitfenster: 1 day
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The association of percent liver fat with insulin resistance as measured by HOMA-IR will be measured by correlation/regression. |
1 day
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The association of percentage liver fat by magnetic resonance spectroscopy with triglycerides
Zeitfenster: 1 day
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The association of percent liver fat with triglycerides will be measured by correlation/regression. |
1 day
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The association of percentage liver fat by magnetic resonance spectroscopy with visceral adipose tissue (VAT)
Zeitfenster: 1 day
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The association of percent liver fat with visceral adipose tissue (VAT) will be measured by correlation/regression. |
1 day
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The association of percentage liver fat by magnetic resonance spectroscopy with total body adipose tissue
Zeitfenster: 1 day
|
The association of percent liver fat with total body adipose tissue will be measured by correlation/regression. |
1 day
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Aviva Sopher, MD, MS, MS, Columbia University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Sopher AB, Grigoriev G, Laura D, Cameo T, Lerner JP, Chang RJ, McMahon DJ, Oberfield SE. Anti-Mullerian hormone may be a useful adjunct in the diagnosis of polycystic ovary syndrome in nonobese adolescents. J Pediatr Endocrinol Metab. 2014 Nov;27(11-12):1175-9. doi: 10.1515/jpem-2014-0128.
- Sopher AB, Gerken AT, Blaner WS, Root JM, McMahon DJ, Oberfield SE. Metabolic manifestations of polycystic ovary syndrome in nonobese adolescents: retinol-binding protein 4 and ectopic fat deposition. Fertil Steril. 2012 Apr;97(4):1009-15. doi: 10.1016/j.fertnstert.2012.01.111. Epub 2012 Feb 17.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Erkrankungen des endokrinen Systems
- Pathologische Prozesse
- Neubildungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Stoffwechselerkrankungen
- Erkrankungen des Verdauungssystems
- Genitalerkrankungen, weiblich
- Störungen des Glukosestoffwechsels
- Leberkrankheiten
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Hautkrankheiten
- Insulinresistenz
- Hyperinsulinismus
- Haarkrankheiten
- Eierstockzysten
- Zysten
- Störungen des Fettstoffwechsels
- Virilismus
- Menstruationsstörungen
- Fettleber
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Haut- und Bindegewebserkrankungen
- Anzeichen und Symptome
- Metabolisches Syndrom
- PCO-Syndrom
- Nicht alkoholische Fettleber
- Dyslipidämien
- Hirsutismus
- Amenorrhoe
Andere Studien-ID-Nummern
- AAAA7793
Plan für individuelle Teilnehmerdaten (IPD)
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