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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00552955
First received: November 1, 2007
Last updated: March 26, 2014
Last verified: March 2014
  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

Study Type: Observational
Official Title: Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis

Resource links provided by NLM:


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

Enrollment: 35
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552955

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Angelo M Taveira-DaSilva, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00552955     History of Changes
Other Study ID Numbers: 080016, 08-H-0016
Study First Received: November 1, 2007
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Sclerosis
Tuberous Sclerosis
Lymphangiomyoma
Lymphangioleiomyomatosis
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hamartoma
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development
Nervous System Malformations
Nervous System Diseases
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Perivascular Epithelioid Cell Neoplasms
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on August 28, 2014