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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552955
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date November 1, 2007
First Posted Date November 2, 2007
Last Update Posted Date March 6, 2019
Study Start Date October 26, 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
Official Title Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis
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....

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.
Study Type Observational
Study Design Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Lymphangioleiomyomas
  • Tuberous Sclerosis
  • Lymphangioleiomyomatosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2012)
35
Original Enrollment
 (submitted: November 1, 2007)
30
Study Completion Date March 21, 2016
Primary Completion Date Not Provided
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 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00552955
Other Study ID Numbers 080016
08-H-0016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Angelo M Taveira-DaSilva, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 21, 2016