| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Narcolepsy |
| Purpose: |
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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 Participants are withdrawn from their narcolepsy medication and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 draw...
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| Study summary: |
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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. |
| Criteria: |
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- INCLUSION CRITERIA:
Patients
-18 to 55 year old men and pre-menopausal women with current narcolepsy, otherwise
healthy.
Controls
-18 to 55 year old healthy men and pre-menopausal women.
SUBJECTS WITH NARCOLEPSY INCLUSION:
- Having a current diagnosis of narcolepsy with moderate or severe daytime sleepiness
for at least 6 months, according to the International Classification of Sleep
Disorder (ICSD).
- Both new and previously diagnosed patients are eligible.
- Females of childbearing potential must have a negative serum pregnancy test.
- A valid barrier contraception method is required over the duration of the study.
- Patients must agree to refrain from operating a motor vehicle and from being involved
in any other potentially hazardous activity during the tapering off and the drug-free
periods.
SUBJECTS WITH NARCOLEPSY EXCLUSION:
- Pregnancy and lactation (women only)
- Use of birth control pills
- Menopause, defined as 6 consecutive months without mensis
- Clinical diagnosis of polycystic ovary disease, chronic history of anovulatory cycles
or other alterations of the menstrual cycle (for women only)
- Use of any experimental drug or current participation in another research protocol
- Chronic amphetamines in the last 2 months and any drug known to influence the
autonomic nervous system including appetite suppressants
- Excessive daytime sleepiness (EDS) related to:
- Sleep apnea
- Periodic limb movements
- Substance disorder or alcohol consumption
- Any concurrent psychiatric, neurological, neoplastic, endocrinologic, or infectious
disease that may contribute to EDS
- Insufficient sleep (less than 6 hours/night) or any other known cause inducing
sleepiness
- Working in an occupational environment that requires variable or routine night shifts
- History of head trauma or history of seizure
- Agitated state or severe anxiety, moderate or severe psychosis or dementia
- Current major depression (Hamilton score greater than 18), subjects currently
receiving pharmacological treatment for depression (even if their Hamilton score is
lower than 18), anyone who has or had suicidal ideation
- Dyskinesia or other neurological conditions
- Use of any medications that may influence sleep or contribute to EDS, except for
anticataplectic medications, including:
Hypnotic, anxiolytic, chronic amphetamine use, antidepressants, antihistamine, clonidine,
anticonvulsants
- Hyperthyroidism or hypothyroidism
- Symptomatic cardiac disease
- For those subjects consenting to the exercise test (Cooper test)
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
- Chronic illicit drug use
- Use of antipsychotic drugs
- Narcoleptic subjects with coexistent significant sleep apnea or respiratory
disturbances are excluded
- Major cardiac rhythm disturbances, respiratory rate alterations, or any other major
organ disease that would make the interpretation of HRV data arduous
- Fever
EXCLUSION RELATED TO THE METABOLIC STATUS:
- Weight fluctuations defined as increase or decrease in body weight greater than 5%
over the last 3 months
- Unstable physical activity in the 3 months prior to study entry
- Any secondary cause of obesity, including:
- Cushing syndrome, hypothyroidism, GH and testosterone deficiency, polycystic ovarian
syndrome, insulinoma, hypothalamic lesions, and genetic obesity syndromes such as
Prader-Willy and other genetic syndromes
- Obesity-related medical conditions requiring pharmacological treatment
- Insulin-dependent diabetes mellitus
- Uncontrolled hypertension
- Uncontrolled hyperlipidemia
- Current smoking, defined as more than 2 cigarettes/day
- Strict vegetarian diet, defined as lack of milk, eggs, and diary products
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. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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