- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00920842
Study of Metabolic Syndrome in Adolescent and Young Adult Survivors of Childhood Leukemia Who Have Undergone Stem Cell Transplant
Metabolic Syndrome Following Transplant for Leukemia
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.
연구 개요
상태
상세 설명
OBJECTIVES:
- To determine the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) and compare the extent to which prevalence is higher in HSCT survivors than in age- and gender-matched population norms derived from the Third National Health and Nutrition Examination Survey (NHANES III).
- To evaluate the relationship between insulin resistance and risk factors associated with metabolic syndrome (e.g., hypertension, obesity, hyperinsulinemia, and dyslipidemia) as measured by euglycemic insulin clamp, fasting serum insulin, glucose, lipids (total cholesterol, triglycerides, LDL-C, and HDL-C), blood pressure and anthropometric measurements, and DEXA scan in these patients and compare to age- and gender-matched population norms.
- To assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of metabolic syndrome and that may be altered after HSCT, including growth hormone secretion, adipokines (adiponectin and leptin), and inflammatory mediators (interleukin-6, tumor necrosis factor-α, and C-reactive protein).
- To evaluate the association of metabolic syndrome and early signs of impaired endothelial function and cardiovascular changes.
- To evaluate health behaviors related to prevention of cardiovascular disease, diabetes, and obesity, including a physical activity assessment, a dietary assessment, and a health knowledge assessment that will be used in the analyses of metabolic syndrome, growth hormone deficiency, and indicators of cardiovascular disease.
OUTLINE: Patients are stratified according to post-transplant follow-up period (2-9 years vs 10-15 years vs > 15 years).
Patients and their siblings undergo physical examination, a review of medical and family history, and blood pressure and anthropometric measurements. Patients and their siblings also undergo blood sample collection for laboratory studies (including analysis of C-reactive protein and CBC; lipid profile and triglycerides; leptin and adipokines; free thyroxine, TSH, IGF1, IGF3, and LH; and estradiol [females] or testosterone [males]); urine sample collection for microalbumin determination; and other study procedures (including euglycemic insulin clamp study; body composition and bone density [DEXA] study; bone-age x-ray [for patients < 18 years of age]; and vascular studies). Patients also undergo growth hormone stimulation testing.
Patients and their siblings complete questionnaires about their physical activity, dietary habits, and health knowledge.
PROJECTED ACCRUAL: A total of 193 childhood leukemia survivors and 193 healthy siblings will be accrued for this study.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98105
- Clinical Research Center - Seattle Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Survivor of childhood leukemia, meeting all of the following criteria:
- 21 years of age and under at diagnosis
- Has undergone hematopoietic stem cell transplantation (HSCT) at Fairview University Medical Center or Fred Hutchinson Cancer Research Center ≥ 2 years ago
- Disease in remission
- Healthy sibling of a childhood leukemia survivor
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Comparison of the prevalence of metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone hematopoietic stem cell transplantation (HSCT) with age- and gender-matched controls
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Comparison of insulin resistance in patients with age- and gender-matched controls
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation between insulin sensitivity and risk factors associated with metabolic syndrome
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Influence of time since transplant on insulin resistance
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Peak growth hormone secretion in patients with insulin resistance and in those without
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Growth hormone deficiency in patients with metabolic syndrome and in those without
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Association of interleukin-6, tumor necrosis factor-α, C-reactive protein, and leptin with insulin resistance and central obesity
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Correlation of adiponectin with insulin resistance and central obesity
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Differences in markers for endothelium dysfunction and early indicators of cardiovascular disease
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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Difference in important health behaviors related to obesity and cardiovascular disease between patients with metabolic syndrome and those without
기간: ≥2 years post-HSCT
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≥2 years post-HSCT
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공동 작업자 및 조사자
수사관
- 수석 연구원: K S Baker, MD, MS, Fred Hutchinson Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IR 7141
- P30CA077598 (미국 NIH 보조금/계약)
- UMN-2003NT063
- CDR0000642276 (레지스트리 식별자: NCI)
- IR-6980 (기타 식별자: Former FHCRC IRB ID)
- FHCRC-2357.00 (기타 식별자: Former FHCRC ID)
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