NarcolepsyNCT00283894
Body Weight Regulation in Patients With Narcolepsy
An observational study of Narcolepsy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2006to 19 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Show all 39Show fewer
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
- 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.
Read the detailed description
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.
- Conditions
- Narcolepsy
- Keywords
- Obesity, Leptin, Sleep Attacks, Energy Metabolism, Healthy Control, Narcolepsy, Healthy Volunteer, HV
- Medical subject headings
- Narcolepsy, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study start20 Jan 2006
- Study completion19 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Giovanni Cizza, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283894
- Sponsor's protocol ID
- 060079
- Other IDs
- 06-DK-0079
- Status last verified
- 19 Jun 2013
- First submitted
- 29 Jan 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Blanco M, Gallego R, Garcia-Caballero T, Dieguez C, Beiras A. Cellular localization of orexins in human anterior pituitary. Histochem Cell Biol. 2003 Oct;120(4):259-64. doi: 10.1007/s00418-003-0562-z. Epub 2003 Aug 28.
PubMed 14574580Buchholz K, Schachinger H, Wagner M, Schorr U, Sharma AM, Deter HC. Enhanced affective startle modulation in salt-sensitive subjects. Hypertension. 2001 Dec 1;38(6):1325-9. doi: 10.1161/hy1101.096055.
PubMed 11751712Chabas D, Taheri S, Renier C, Mignot E. The genetics of narcolepsy. Annu Rev Genomics Hum Genet. 2003;4:459-83. doi: 10.1146/annurev.genom.4.070802.110432.
PubMed 14527309
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Orexin System in Body Weight Regulation: Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT00283894
- Acronym / sponsor ID
- 060079
- Conditions
- Narcolepsy
- Keywords
- Obesity, Leptin, Sleep Attacks, Energy Metabolism, Healthy Control, Narcolepsy, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 20 Jan 2006
- Study completion
- 19 Jun 2013
- First posted
- 30 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (39 listed)
- 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.
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 14574580Blanco M, Gallego R, Garcia-Caballero T, Dieguez C, Beiras A. Cellular localization of orexins in human anterior pituitary. Histochem Cell Biol. 2003 Oct;120(4):259-64. doi: 10.1007/s00418-003-0562-z. Epub 2003 Aug 28.
- Background: PubMed 11751712Buchholz K, Schachinger H, Wagner M, Schorr U, Sharma AM, Deter HC. Enhanced affective startle modulation in salt-sensitive subjects. Hypertension. 2001 Dec 1;38(6):1325-9. doi: 10.1161/hy1101.096055.
- Background: PubMed 14527309Chabas D, Taheri S, Renier C, Mignot E. The genetics of narcolepsy. Annu Rev Genomics Hum Genet. 2003;4:459-83. doi: 10.1146/annurev.genom.4.070802.110432.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Cizza, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283894, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.