Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents
This trial is active, not recruiting.
|Conditions||obesity, insulin resistance|
|Treatment||caloric restrictive diet|
|Collaborator||National Institutes of Health (NIH)|
|Start date||May 2011|
|End date||July 2014|
|Trial size||40 participants|
|Trial identifier||NCT01901978, 1007007067-Adipocyte Study, R01HD040787|
The purpose of this study is to investigate the changes in subcutaneous adipocyte size, number and gene expression after weight loss and to assess whether those changes contribute to decreases in ectopic fat accumulation and insulin resistance in women between ages of 16-32.
|Intervention model||single group assignment|
|Primary purpose||health services research|
Caloric restrictive diet
Abdominal fat re-distribution with weight loss
time frame: 12 weeks
Adipocyte cell size distrubtion and gene expression
time frame: 12 week
Female participants from 16 years up to 32 years old.
Inclusion Criteria: - Women ages 16-32 Exclusion Criteria: - They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil. Patients on diuretics will be excluded.
|Official title||Study to Investigate Benefits of Weight Loss in Yound Adults and Adolescents|
|Principal investigator||Sonia Caprio, MD|
|Description||There are no studies in young women that have prospectively studied changes in fat cell size, gene expression and insulin sensitivity during the transition from overweight/obese to normal weight. Our preliminary data suggest that the presence of ectopic fat accumulation and insulin resistance in obese children could be considered an "early phase" in the development of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity. Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due to a decrease in mean adipocyte cell size, but not cell number.|
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