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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Queen's University, Kingston, Ontario Weill Medical College of Cornell University |
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00510315 |
Purpose
The purpose of this study is to better understand why some women who survived leukemia 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.
| Condition | Intervention |
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Leukemia |
Other: Questionnaires, Laboratory tests, Abdominal MRI |
| MedlinePlus related topics: | Cancer Cholesterol Leukemia, Adult Acute Leukemia, Adult Chronic Obesity |
| ChemIDplus related topics: | Insulin Insulin-like growth factor I Mecasermin rinfabate Dextrose Leptin Lipids |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Leukemia Following Total Body Irradiation and Stem Cell Transplant |
whole blood
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
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Women treated with SCT/TBI
Cancer diagnosis: AML = 10 ALL = 10 CML = 10 |
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
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1:1 Matched group of women
Current age + or - 2 years Race and ethnicity Cancer diagnosis Interval from completion of cancer therapy to study + or - 2 years |
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
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We will enroll 60 female participants in this study. From the population of interest, female leukemia survivors 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 - 44 years of age at the time of study.
Eligibility
| Ages Eligible for Study: | 18 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Potential research subjects will be identified by a member of the research team from the SCT database and the medicine and pediatrics leukemia databases.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kevin Oeffinger, MD | 212-639-8469 | oeffingk@mskcc.org |
| Contact: Charles Sklar, MD | 212-639-8138 | sklarc@mskcc.org |
| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting | ||||
| New York, New York, United States, 10021 | |||||
| Contact: Kenneth Oeffinger, MD | |||||
| Contact: Charles Sklar, MD | |||||
| Principal Investigator: Kenneth Oeffinger, MD | |||||
| Memorial Sloan-Kettering Cancer Center |
| Queen's University, Kingston, Ontario |
| Weill Medical College of Cornell University |
| Principal Investigator: | Kenneth Oeffinger, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Memorial Sloan-Kettering Cancer Center
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| Responsible Party: | Memorial Sloan Kettering Cancer Center ( Kevin Oeffinger, MD ) |
| Study ID Numbers: | 07-092 |
| First Received: | July 31, 2007 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00510315 |
| Health Authority: | United States: Institutional Review Board |
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