Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510315
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2007-07-31
Brief Title:
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related Illness Following Total Body Irradiation and Stem Cell Transplant
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Abdominal Obesity and Cardiovascular Risk Factors in Women Who Survived Cancer or a Related IllnessFollowing Total Body Irradiation and Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None