NCT00510315

Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant

Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia
• Hodgkin's Lymphoma
• Non-Hodgkin's Lymphoma
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
OTHER	Questionnaires, Laboratory tests, Abdominal MRI	Height, weight, waist and hip circumference; systolic and diastolic blood pressure; questionnaires; fasting blood tests: insulin, glucose, lipids (low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides, LDL pattern, HDL and LDL subspecies), cardiac inflammatory markers (hsCRP, IL-1B, IL-6, IL-10, TNFa), leptin, adiponectin, IGF-1, and IGFBP3; abdominal MRI for visceral and subcutaneous fat measurement

Timeline

• Start date: 2007-07-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2007-08-02
• Last updated: 2020-12-07

Locations

1 site across 1 country: United States