Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283894
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2006-01-29
Brief Title:
Body Weight Regulation in Patients With Narcolepsy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Role of the Orexin System in Body Weight Regulation Patients With Narcolepsy
Status:
COMPLETED
Status Verified Date:
2013-06-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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subjects and people with narcolepsy between 18 and 55 years of age may be eligible for this study Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications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
Walkingrunning test to assess level of physical conditioning
Dexamethasone CRH corticotropin-releasing hormone suppression test and CRH stimulation test Subjects receive eight doses of 05 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
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
Walkingrunning test to assess level of physical conditioning
Dexamethasone CRH corticotropin-releasing hormone suppression test and CRH stimulation test Subjects receive eight doses of 05 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0079 | None | None | None |