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
40 Years
70 Years
Female
Obesity
Trial Information
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
samples.
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
level.
Inclusion Criteria:
- 40-70 years of age
- Post-menopausal women defined as: 24 consecutive months without a menstrual period,
currently not taking any medication known to induce amenorhea
- Body Mass Index 35-50
Exclusion Criteria:
- History of any bleeding disorder
- HIV positive
- History of previous weight loss surgery.
- History of Inflammatory Bowel Disease
- History of any other malignancy other than non-melanoma skin cancer in the past 5
years
- Currently taking fish oil, omega-3 supplements or other herbal supplements that
exceed GRAS (Generally Recognized as Safe) levels
- Currently taking any estrogen/progesterone hormones except vaginal cream
- Smokers (or stopped < 3 months ago)
- Currently taking any medication that can alter fat stores as determined by the
principal investigator
- Currently taking any weight control medication
- Currently taking hypoglycemic medications.
- Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin
81mg may be permitted if the Framingham Risk Score is < 10
- Currently taking anticoagulant medication or stopped <30 days ago.
- Screening fasting blood glucose >165mg/dL
- Screening thyroid function test abnormal
- Screening LFT results > 2X upper limit of normal
- Screening creatinine > 2X upper limit of normal
- Any condition or situation which, in the opinion of the investigator, puts the
patient at significant risk, could complicate the study results, or may interfere
significantly with participation in the study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Adipose tissue inflammation via crown-like structures
Outcome Description:
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.
Outcome Time Frame:
9 weeks
Safety Issue:
No
Principal Investigator
Peter R. Holt, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Rockefeller University
Authority:
United States: Institutional Review Board
Study ID:
PHO-0785
NCT ID:
NCT01699906
Start Date:
September 2012
Completion Date:
September 2016
Related Keywords:
- Obesity
- Obesity
- Inflammation
- Obesity
- Weight Loss
Name | Location |
|---|---|
| The Rockefeller University | New York, New York 10065 |
