- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
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
Exclusion Criteria:
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Women treated with SCT/TBI
|
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
|
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 |
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: within 12 months
|
within 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the differences in processes of changes, decisional balance for physical activity, body image, mood, and quality of life between the groups
Tidsramme: within 12 months
|
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.
Tidsramme: within 12 months
|
within 12 months
|
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.
Tidsramme: within 12 months
|
within 12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kenneth Oeffinger, MD, Memorial Sloan Kettering Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Benmargssykdommer
- Hematologiske sykdommer
- Overernæring
- Ernæringsforstyrrelser
- Forstadier til kreft
- Overvekt
- Lymfom
- Myelodysplastiske syndromer
- Leukemi
- Hodgkins sykdom
- Lymfom, Non-Hodgkin
- Preleukemi
- Overvekt, mage
Andre studie-ID-numre
- 07-092
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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