Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women



Status:Completed
Conditions:Lymphoma, Neurology, Endocrine
Therapuetic Areas:Endocrinology, Neurology, Oncology
Healthy:No
Age Range:18 - 80
Updated:2/16/2018
Start Date:October 26, 2007
End Date:March 21, 2016

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Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis

This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed
from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that
these tumors increase in size in the evening, but this result could stem from the fact that
previous study participants were tested after eating lunch. The purpose of the study is to
help researchers understand the factors that produce changes in size of lymphangioleiomyomas,
as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas
and avoid confusing these tumors with other malignant tumors.

Volunteers must be women who are at least 18 years of age and who have been diagnosed with
lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney
transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a
physical examination and medical history.

During the study, participants will be admitted to a National Institutes of Health clinical
center for three days to undergo a number of tests. Tests will include routine blood and
urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic
ultrasounds....

Lymphangioleiomyomatosis (LAM) is a rare disease of women that is characterized by a
proliferation of abnormal smooth muscle-like cells (LAM cells) in the lungs, which leads to
cystic destruction of the lung parenchyma, in the axial lymphatics, resulting in
lymphangioleiomyomas, and in abdominal angiomyolipomas, primarily in the kidneys.
Lymphangioleiomyomas may cause abdominal distension and compress abdominal organs, producing
obstipation, bladder obstruction and neurological deficits. Leakage of chyle may be
responsible for ascites and pleural effusions. The lymphangioleiomyomas may change in size
during the day. This variation in tumor size may be due to increased chyle formation or
alterations in lymphatic flow. These studies however, were not performed with research
subjects who were fasting. Our hypothesis is that the ingestion of food increases chyle
formation and lymphatic flow, which in turn increases the size of the lymphangioleiomyomas.
The aim of this study is to test this hypothesis. We propose to conduct a study in 30 LAM
patients who have lymphangioleiomyomas to determine whether the ingestion of food, by
increasing chyle formation and lymphatic flow, increases the size of the
lymphangioleiomyomas.

- INCLUSION CRITERIA:

Individuals who are 18 years of age or older with any of the following:

1. Lymphangioleiomyomatosis

2. Abdominal or pelvic lymphangioleiomyomas equal to or greater than one centimeter in
diameter in the non-fasting state.

EXCLUSION CRITERIA:

Individuals with any of the following:

1. Lung transplantation

2. Kidney transplantation

3. Lymphangioleiomyomas smaller than one centimeter in diameter in the non-fasting state.

4. Pregnancy or lactation.

5. Type 1 diabetes.

6. Inability to give informed consent.

7. Currently taking rapamycin.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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