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NCT00283894 · ClinicalTrials.gov registry record
Body Weight Regulation in Patients With Narcolepsy
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 30
- Enrollment target
NCT00283894 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 participants.
The verdict
NCT00283894 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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 Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications.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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-01-20 |
| Est. Completion | 2013-06-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00283894
The ClinicalTrials.gov registry entry for NCT00283894 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00283894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00283894 about?
NCT00283894 is a clinical study titled "Body Weight Regulation in 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 ...
What is the current status of trial NCT00283894?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2006-01-20. Estimated completion is 2013-06-19.
Who is sponsoring clinical trial NCT00283894?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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