Diet Induced Weight Loss Reduces Inflammation and Crown-like Structures and Corrects Immune Dysfunction in Subcutaneous Adipose Tissue In Class 2-3 Obese Women: A Pilot Study
This study aims to determine if weight loss of about 10% of initial weight lowers evidence
of inflammation in fat stores. It is likely that, if fat store inflammation is reduced,
then inflammation in breast fat also will be lower. Also, it is possible that blood immune
cells may be changed with weight loss and even that immune cells in skin will be affected.
Since vitamin D has important immune effects and vitamin D is low in obesity, we also want
to study what happens to this vitamin during weight loss.
This pilot study of weight loss will be done in 10 very obese post menopausal women. This
study will include nutritional and medical evaluation, a 3 day inpatient hospital stay
eating a diet providing 50% of what they were taking before starting the study and then a
nutritionally adequate diet that will allow them to lose about 10% of their initial weight
within 7 to 10 week period. They will have about 4-5 grams of fat removed by suction
through a syringe and a biopsy of the skin in addition to studies of blood and stool
When they have completed the study with a 10% body weight loss they will be referred to a
nutrition clinic which can counsel them to continue a slower weight loss to an optimal
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Adipose tissue inflammation via crown-like structures
Diet-induced weight loss of 10% body weight will result in reduction in abdominal subcutaneous fat inflammation as measured by: reduction in adipocyte size determined by microscopy and of CLS number in adipose tissue. reduction in inflammatory gene expression determined by PCR and selected cytokine protein levels. increased anti-inflammatory lymphocytes determined by immunohistochemistry or by flowcytometry.
Peter R. Holt, MD
The Rockefeller University
United States: Institutional Review Board
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