NAFLD hos ungdom og unge voksne med PCOS
Ikke-alkoholisk fettleversykdom (NAFLD), insulinresistens og dyslipidemi hos ungdom og unge voksne med polycystisk ovariesyndrom (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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Healthy adolescent girls and young women 14 - 25 years with and without PCOS
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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. |
|
Control subjects
Forty unaffected adolescents and young adults between the ages of 14 and 25 years at least two years past menarche. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in percentage liver fat between PCOS and controls in adolescents and young adults
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.
Tidsramme: 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
Tidsramme: 1 day
|
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)
Tidsramme: 1 day
|
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
Tidsramme: 1 day
|
The association of percent liver fat with total body adipose tissue will be measured by correlation/regression. |
1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Aviva Sopher, MD, MS, MS, Columbia University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Patologiske prosesser
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Metabolske sykdommer
- Sykdommer i fordøyelsessystemet
- Kjønnssykdommer, kvinner
- Glukosemetabolismeforstyrrelser
- Leversykdommer
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Gonadal lidelser
- Hudsykdommer
- Insulinresistens
- Hyperinsulinisme
- Hårsykdommer
- Cyster på eggstokkene
- Cyster
- Lipidmetabolismeforstyrrelser
- Virilisme
- Menstruasjonsforstyrrelser
- Fettlever
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Hud- og bindevevssykdommer
- Tegn og symptomer
- Metabolsk syndrom
- Polycystisk ovariesyndrom
- Ikke-alkoholisk fettleversykdom
- Dyslipidemier
- Hirsutisme
- Amenoré
Andre studie-ID-numre
- AAAA7793
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
We will consider this
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