Body Weight Regulation in Patients With Narcolepsy
|First Received Date ICMJE||January 29, 2006|
|Last Updated Date||December 7, 2013|
|Start Date ICMJE||January 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00283894 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Body Weight Regulation in Patients With Narcolepsy|
|Official Title ICMJE||The Role of the Orexin System in Body Weight Regulation: Patients With Narcolepsy|
This study will measure energy expenditure (the rate at which the body burns calories), physical activity and caloric intake in people with narcolepsy to learn more about how the risk of becoming overweight or diabetic may be affected.
Healthy control subjects and people with narcolepsy between 18 and 55 years of age may be eligible for this study. Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications.
BACKGROUND: Several cross-sectional studies have suggested that subjects with narcolepsy have increased body mass index (BMI) and insulin resistance. These subjects exhibit a decrease in cerebrospinal fluid (CSF) orexin levels, which has been causally linked to the clinical manifestations of this disease. Orexins are peptides expressed in a brain region, the lateral hypothalamic area, which stimulate appetite and modulate sleep. Low CSF orexin levels provoke narcolepsy-like behavior, such as excessive daytime sleepiness and a sudden loss of muscle tone known as cataplexy.
OBJECTIVES: The primary objective of this study is to determine whether subjects with narcolepsy have lower energy expenditure compared to healthy matched controls. In addition, we will assess food intake, physical activity, and other relevant parameters.
STUDY POPULATION: 18 to 55 year old men and premenopausal women with narcolepsy and healthy matched controls
DESIGN: This is a cross-sectional, case-controlled study of subjects with narcolepsy matched on a one-to-one basis with healthy, non-narcoleptic control subjects.
OUTCOME PARAMETERS: We will assess metabolic, hormonal, and energy expenditure parameters in subjects with narcolepsy. Outcomes: energy expenditure by various methods (indirect calorimetry, metabolic chamber, doubly-labeled water method); leptin circadian levels (frequent 24h sampling); physical activity, characterization of the main endocrine axes, and other relevant parameters.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
-18 to 55 year old men and pre-menopausal women with current narcolepsy, otherwise healthy.
-18 to 55 year old healthy men and pre-menopausal women.
SUBJECTS WITH NARCOLEPSY INCLUSION:
SUBJECTS WITH NARCOLEPSY EXCLUSION:
Hypnotic, anxiolytic, chronic amphetamine use, antidepressants, antihistamine, clonidine, anticonvulsants
Any medical contraindication to exercise of moderate intensity and short duration including cardiovascular or respiratory conditions, morbid obesity, and severe osteoarthritis of the lower extremities
EXCLUSION RELATED TO THE METABOLIC STATUS:
HEALTHY CONTROL SUBJECT INCLUSION/EXCLUSION:
-In addition to the criteria specified above, healthy controls must be in good physical health and not on chronic medications.
|Ages||18 Years to 55 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00283894|
|Other Study ID Numbers ICMJE||060079, 06-DK-0079|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP