Tuberous Sclerosis Clinical Trial
Official title:
Effect of Fasting on the Size of Lymphangioleiomyomas in Patients With Lymphangioleiomyomatosis
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....
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06139172 -
Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities
|
N/A | |
Recruiting |
NCT00001532 -
Role of Genetic Factors in the Development of Lung Disease
|
||
Recruiting |
NCT03422367 -
JASPER Early Intervention for Tuberous Sclerosis
|
N/A | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Unknown status |
NCT00490789 -
Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM
|
Phase 2 | |
Recruiting |
NCT04463316 -
GROWing Up With Rare GENEtic Syndromes
|
||
Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
Enrolling by invitation |
NCT03836300 -
Parent and Infant Inter(X)Action Intervention (PIXI)
|
N/A | |
Completed |
NCT02104011 -
Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers
|
Phase 2 | |
Recruiting |
NCT02461459 -
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
|
||
Completed |
NCT01526356 -
Topical Rapamycin to Erase Angiofibromas in TSC
|
Phase 2 | |
Withdrawn |
NCT03254680 -
Turmeric as Treatment in Epilepsy
|
N/A | |
Terminated |
NCT01092208 -
Studies of Autistic Patients: Gene Networks and Clinical Subtypes
|
||
Active, not recruiting |
NCT01954693 -
A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis
|
Phase 2 | |
Completed |
NCT03826628 -
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
|
Phase 2/Phase 3 | |
Completed |
NCT00989742 -
Doxycycline In Lymphangioleiomyomatosis (LAM)
|
Phase 4 | |
Recruiting |
NCT05286632 -
KidneYou - Innovative Digital Therapy
|
N/A | |
Withdrawn |
NCT04344626 -
Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery
|
N/A | |
Recruiting |
NCT05199402 -
Clinical Trial Data Set Re-use With Statistical Methodologies Tailored for Clinical Trials in Rare Diseases
|
||
Recruiting |
NCT00001975 -
Study of Skin Tumors in Tuberous Sclerosis
|