Body Weight Regulation in Patients With Narcolepsy

NCT00283894 | Completed

• 2 other identifiers: 06007906-DK-0079
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications.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.
• 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.

Conditions

Narcolepsy

Keywords

Obesity; Leptin; Sleep Attacks; Energy Metabolism; Healthy Control; Narcolepsy; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients
• to 55 year old men and pre-menopausal women with current narcolepsy, otherwise healthy.
• Controls
• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 14574580 BACKGROUND

• Buchholz 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.

  PMID: 11751712 BACKGROUND

• Chabas 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.

  PMID: 14527309 BACKGROUND

MeSH Terms

Conditions

Narcolepsy; Obesity

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Cizza, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 29, 2006
• First Posted: January 30, 2006
• Study Start: January 20, 2006
• Study Completion: June 19, 2013
• Last Updated: October 6, 2017

Record last verified: 2013-06-19

Locations

US (1)