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

NCT00552955 | Completed

• 2 other identifiers: 08001608-H-0016
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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....

Conditions

Lymphangioleiomyomas; Tuberous Sclerosis; Lymphangioleiomyomatosis

Keywords

Lymphangioleiomyomatosis; Abdominal Lymphangioleiomyomas; Chyle; Ascites; Tuberous Sclerosis Complex; LAM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are 18 years of age or older with any of the following:
• Lymphangioleiomyomatosis
• Abdominal or pelvic lymphangioleiomyomas equal to or greater than one centimeter in diameter in the non-fasting state.

You may not qualify if:

• Individuals with any of the following:
• Lung transplantation
• Kidney transplantation
• Lymphangioleiomyomas smaller than one centimeter in diameter in the non-fasting state.
• Pregnancy or lactation.
• Type 1 diabetes.
• Inability to give informed consent.
• Currently taking rapamycin.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1164/ajrccm.151.2.7842216.

  PMID: 7842216 BACKGROUND

• 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. doi: 10.1378/chest.115.4.1041.

  PMID: 10208206 BACKGROUND

• Johnson SR, Tattersfield AE. Clinical experience of lymphangioleiomyomatosis in the UK. Thorax. 2000 Dec;55(12):1052-7. doi: 10.1136/thorax.55.12.1052.

  PMID: 11083892 BACKGROUND

MeSH Terms

Conditions

Lymphangiomyoma; Tuberous Sclerosis; Lymphangioleiomyomatosis; Ascites

Condition Hierarchy (Ancestors)

Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hamartoma; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Perivascular Epithelioid Cell Neoplasms; Neoplasms, Connective and Soft Tissue; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angelo M Taveira-DaSilva, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: October 26, 2007
• Study Completion: March 21, 2016
• Last Updated: March 6, 2019

Record last verified: 2016-03-21

Locations

US (1)