PCOS가 있는 청소년 및 청년의 NAFLD
다낭성 난소 증후군(PCOS)이 있는 청소년 및 청년의 비알코올성 지방간 질환(NAFLD), 인슐린 저항성 및 이상지질혈증
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Healthy adolescent girls and young women 14 - 25 years with and without PCOS
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in percentage liver fat between PCOS and controls in adolescents and young adults
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The association of percentage liver fat by magnetic resonance spectroscopy with insulin resistance as measured by HOMA-IR.
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Aviva Sopher, MD, MS, MS, Columbia University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AAAA7793
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
We will consider this
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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