Body Weight Regulation in Patients With Narcolepsy
|ClinicalTrials.gov Identifier: NCT00283894|
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : October 6, 2017
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 Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications.
- Blood draw for genetic studies.
- Collection of a cerebrospinal fluid sample.
- Diet to keep subjects' weight constant.
- Activity watch, using a device worn on the wrist to measure amount of movement, and an activity monitor worn at the waist to measure physical activity and caloric expenditure.
- Questionnaires about sleepiness, symptoms, food intake, exercise and mood.
- 24-hour urine collection and 24-hour blood draw to measure hormones.
- Glucose tolerance test. The subject drinks a sugar solution and blood samples are collected through a catheter before drinking the solution and 30 minutes, 1, 2 and 3 hours after drinking it.
- Startle reflex test. Subjects hear a loud noise through headphones and are asked to look at pictures.
- Sleep study to evaluate sleep-related breathing disturbances and record information about sleep stages.
- Indirect calorimetry test to measure how fast the body uses calories. A plastic canopy is placed over the face for several minutes to capture the air exhaled to analyze oxygen use. To measure the energy associated with meals, the same measurements are taken after the subject eats lunch.
- CT scan of the abdomen to see how much fat is deposited in the abdomen, and DEXA scan of the whole body to see the percentage of fat and muscle.
- Plethysmography. Participants sit in an enclosed chamber while the mass and volume of the body are measured by changes in air pressure.
- Neuropsychological testing to assess thought processes.
- Continuous 24-hour heart rate measurement.
- Metabolic chamber. Subjects spend 24 hours in a small room to measure the amount of oxygen inhaled and carbon dioxide exhaled.
- Walking/running test to assess level of physical conditioning.
- Dexamethasone CRH (corticotropin-releasing hormone) suppression test and CRH stimulation test. Subjects receive eight doses of 0.5 mg dexamethasone every 6 hours for a day and a half. After the last dose, two blood samples are drawn, then a dose of CRH is injected, and then six more blood samples are drawn over the next 3 hours.
- TRH (thyrotropin-releasing hormone) stimulation test. Subjects are given TRH through a vein, and several blood samples are then drawn over the next 3 hours.
- Doubly labeled water test. Subjects drink a dose of "heavy" water. Urine samples are collected at 2, 3 and 5 hours after drinking and again for two 4-hour collections a week later.
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||The Role of the Orexin System in Body Weight Regulation: Patients With Narcolepsy|
|Study Start Date :||January 20, 2006|
|Estimated Study Completion Date :||June 19, 2013|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283894
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Giovanni Cizza, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|