Protocol Number: 08-H-0016

Title:

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

Number:

08-H-0016

Summary:

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Children

Male

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Lymphangioleiomyomatosis

Abdominal Lymphangioleiomyomas

Chyle

Ascites

Tuberous Sclerosis Complex

Recruitment Keyword(s):

Lymphangioleiomyomatosis

LAM

Condition(s):

Lymphangioleiomyomas

Tuberous Sclerosis

Lymphangioleiomyomatosis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung, and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Kitaichi M, Nishimura K, Itoh H, Izumi T. Pulmonary lymphangioleiomyomatosis: a report of 46 patients including a clinicopathologic study of prognostic factors. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):527-33.

Chu SC, Horiba K, Usuki J, Avila NA, Chen CC, Travis WD, Ferrans VJ, Moss J. Comprehensive evaluation of 35 patients with lymphangioleiomyomatosis. Chest. 1999 Apr;115(4):1041-52.

Johnson SR, Tattersfield AE. Clinical experience of lymphangioleiomyomatosis in the UK. Thorax. 2000 Dec;55(12):1052-7.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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