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(MGA-0659) Biological Markers of Obesity in Postmenopausal Women

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Methodological Pilot Study: Influence of Fasting Status and Processing Time on Serological Biomarkers of Energy Balance

Principal Investigator:
Mia Gaudet PhD

Jeanne Walker ANP-C

Contact Information:

Telephone: 1-800-RUCARES
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
We are doing this research because there is interest in finding substances in the blood that will improve the ability of doctors and researchers to identify who will be at higher risk of obesity-related diseases (like breast and endometrial cancers, some times called uterine cancer).

Researchers do this type of research in large studies that include women who had blood drawn right after a meal (non-fasting) or hours after they last ate (fasting). Since some of the biological markers of research interest may be higher or lower in the blood right after a meal, the time between last meal and blood draw may be important. In research studies, it is sometimes difficult to separate the drawn blood quickly after it has been drawn. Once blood is outside of the body, it quickly begins to break down, which may affect the biological markers of research interest. So, we are looking at how the time between last meal and blood draw, as well as the time between blood draw and the processing of blood affects the measurement of substances in the blood. We believe that levels of obesity-related metabolic parameters are influenced by processing delays and by fasting status, and further that this latter effect varies by body size.

Detailed Description of Protocol:
This study requires two visits to the Rockefeller University Hospital. The initial visit is the screening visit, which includes a medical history, physical exam, questionnaire, body measurements and glucose test.

If the volunteer passes screening, he or she will be asked to come in for the second visit. The volunteer will come in fasting and an initial blood draw will be taken. The volunteer will be given breakfast, which must be consumed within 20 minutes. Three additional blood draws will be conducted over the following six hours. Afterward, lunch will be provided to the volunteer. Profile:
Healthy Postmenopausal Women

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

-Postmenopausal women
-Ages 50-75

-Has used tobacco products in the previous 6 months
-Currently on hormone replacement therapy or had hormone replacement therapy in the past 6 months
-Allergic to milk, milk products, tree nuts (lactose-intolerance can be accommodated) -Has been diagnosed with diabetes, thyroid disease, HIV, blood clotting disorders, cancer, neurological or psychiatric conditions -Has had chemotherapy or radiation in the previous year



Children permitted to participate:

Potential Benefits.....
There will be no benefit to participants. Instead, others may benefit in the future from what we learn from this study.

There is no cost to volunteers for participating in this research study.

Volunteers will be provided $200.00 upon completion of the study. Volunteers will not be paid for the screening visit.