NAFLD chez les adolescents et les jeunes adultes atteints du SOPK
Maladie du foie gras non alcoolique (NAFLD), résistance à l'insuline et dyslipidémie chez les adolescents et les jeunes adultes atteints du syndrome des ovaires polykystiques (SOPK)
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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- Columbia University Medical Center
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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
Healthy adolescent girls and young women 14 - 25 years with and without PCOS
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Difference in percentage liver fat between PCOS and controls in adolescents and young adults
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.
Délai: 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
Délai: 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)
Délai: 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
Délai: 1 day
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The association of percent liver fat with total body adipose tissue will be measured by correlation/regression. |
1 day
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Aviva Sopher, MD, MS, MS, Columbia University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
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
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Processus pathologiques
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Maladies du système digestif
- Maladies génitales, femme
- Troubles du métabolisme du glucose
- Maladies du foie
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Maladies de la peau
- Résistance à l'insuline
- Hyperinsulinisme
- Maladies des cheveux
- Kystes de l'ovaire
- Kystes
- Troubles du métabolisme lipidique
- Virilisme
- Troubles menstruels
- Foie gras
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladies de la peau et du tissu conjonctif
- Signes et symptômes
- Syndrome métabolique
- Syndrome des ovaires polykystiques
- Stéatose hépatique non alcoolique
- Dyslipidémies
- Hirsutisme
- Aménorrhée
Autres numéros d'identification d'étude
- AAAA7793
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
We will consider this
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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