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Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
First Received: November 1, 2007   Last Updated: October 24, 2008   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00552955
  Purpose

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.


Condition
Lymphangioleiomyomas
Tuberous Sclerosis
Lymphangioleiomyomatosis

Genetics Home Reference related topics: tuberous sclerosis
MedlinePlus related topics: Cancer Tuberous Sclerosis
U.S. FDA Resources
Study Type: Observational
Official Title: Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: October 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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.

EXCLUSION CRITERIA:

Individuals with any of the following:

  1. Lung transplantation
  2. Kidney transplantation
  3. Lymphangioleiomyomas smaller than one centimeter in diameter.
  4. Pregnancy or lactation.
  5. Type 1 diabetes.
  6. Inability to give informed consent.
  7. Currently taking rapamycin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552955

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 080016, 08-H-0016
Study First Received: November 1, 2007
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00552955     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lymphangioleiomyomatosis
Abdominal Lymphangioleiomyomas
Chyle
Ascites
Tuberous Sclerosis Complex
Lymphangioleiomyomatosis
LAM

Study placed in the following topic categories:
Immunoproliferative Disorders
Nervous System Malformations
Lymphangiomyoma
Sclerosis
Neurodegenerative Diseases
Lymphangioleiomyomatosis
Lymphatic Diseases
Tuberous Sclerosis
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Ascites
Bourneville Syndrome
Lymphoproliferative Disorders
Malformations of Cortical Development
Congenital Abnormalities
Neurocutaneous Syndromes

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Nervous System Malformations
Nervous System Diseases
Lymphangiomyoma
Sclerosis
Neurodegenerative Diseases
Hamartoma
Lymphatic Vessel Tumors
Lymphangioleiomyomatosis
Lymphatic Diseases
Neoplasms
Heredodegenerative Disorders, Nervous System
Tuberous Sclerosis
Pathologic Processes
Genetic Diseases, Inborn
Congenital Abnormalities
Malformations of Cortical Development
Lymphoproliferative Disorders
Neurocutaneous Syndromes

ClinicalTrials.gov processed this record on May 06, 2009