Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Explore whether visceral adipose tissue is significantly higher in women who were treated with total body irradiation (TBI) plus stem cell transplant in comparison with women who were not
研究概览
简要总结
The purpose of this study is to better understand why some women who survived cancer or a related illness later develop diabetes, problems with their cholesterol, or other problems that may lead to heart disease. Because these problems may be related to treatment with total body irradiation and a stem cell transplant, the investigators will compare the rates of obesity, cholesterol problems, and diabetes between women who were treated with total body irradiation and a stem cell transplant and women who were not.
The amount and location of fat stores in the abdomen is more important than overall weight or total body fat in the development of diabetes and cholesterol problems. In general, fat can be stored in several areas in the abdomen: around the organs (visceral fat), under the skin (subcutaneous fat), and in the liver (liver fat). People with higher amounts of fat around the organs (visceral fat), even those with a normal weight, are more likely to become diabetic or have high cholesterol. The amount of fat in each of these areas can be measured with an abdominal magnetic resonance imaging (MRI).
In this study, the investigators will use blood tests, height, weight, waist circumference, blood pressure measurements, and an abdominal MRI to evaluate for several risk factors of heart disease, including cholesterol problems, diabetes and pre-diabetes, elevated blood pressure, and increased abdominal fat.
详细描述
We will enroll 60 female participants in this study. From the population of interest, female cancer survivors (or women treated for a related illness) who were treated with TBI prior to a SCT, we will enroll 30 participants, 10 from each of the following cancer groups: acute lymphoblastic leukemia, acute myeloid leukemia, and chronic myeloid leukemia. We are interested in determining the outcomes in adult survivors who have completed their growth by the time of study and yet are younger than the age when most women generally begin to develop insulin resistance or dyslipidemia in the general population. For this reason, we will enroll women who are 18 - 49 years of age at the time of study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Target population
- •Females 18 - 49 years of age at time of study
- •Previous diagnosis of ALL, AML, CML, CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
- •Previously treated with TBI (1200 - 1500 cGy) prior to SCT
- •Free of cancer
- •Two years or more from completion of cancer therapy
- •Able and willing to give informed consent
- •Comparison group
- •Females 18 - 49 years of age at time of study
- •Previous diagnosis of ALL, AML, CML CLL, Hodgkin's lymphoma, Non-hodgkin's lymphoma, aplastic anemia, and myelodysplastic syndrome
- •Free of cancer
- •Two years or more from completion of cancer therapy
- •Able and willing to give informed consent
排除标准
- •Target population
- •Pregnant at time of study
- •Previous cranial radiotherapy (other than TBI)
- •Second primary malignancy (other than non-melanoma skin cancer)
- •Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
- •Currently on a medication for diabetes mellitus or dyslipidemia
- •Patients with a creatinine > 1.5 mg/dL or biopsy-proven chronic active hepatitis
- •Contraindication to an MRI
- •Comparison group
- •pregnant at time of study
- •Previous cranial radiotherapy
- •Second primary malignancy (other than non-melanoma skin cancer)
- •Any patient who has received glucocorticoids or tacrolimus within 60 days prior to the study
- •Currently on a medication for diabetes mellitus or dyslipidemia
- •Patients with a creatinine > 1.5 or biopsy-proven chronic active hepatitis
- •Contraindication to an MRI
结局指标
主要结局
Explore whether visceral adipose tissue is significantly higher in women who were treated with total body irradiation (TBI) plus stem cell transplant in comparison with women who were not
时间窗: within 12 months
次要结局
- To begin to characterize the psychosocial risk factors of the TBI plus stem cell transplant group, in relation to the comparison group, in order to inform a future targeted intervention to reduce risk.(within 12 months)
- Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups(within 12 months)
- Determine the correlation between the amount of visceral adipose tissue and fasting levels of triglycerides, LDL, HDL, insulin, glucose, and HOMA-IR in both groups.(within 12 months)