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NCT00261898 · ClinicalTrials.gov registry record · Phase 2
Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
NCT00261898 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 239 participants.
The verdict
NCT00261898, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
Study Summary
OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive medical problems in recent years. The prevalence of adult obesity has doubled over the past 30 years and continues to increase. In addition, industrial societies attach an economic value to maximizing the waking period to the longest tolerable limit by sleeping as little as possible. Average sleep time has decreased over the last century by 2 hours. Chronically sleeping less has been associated with increased weight, endocrine and metabolic health risks including glucose intolerance, cardiovascular disease, and mortality. The possibility that the current epidemic of obesity and metabolic health risks may be partially related to insufficient sleep is now being recognized. The objective of this proof-of-concept controlled trial is to investigate the impact of increasing sleep time in chronically sleep-deprived, obese subjects. STUDY POPULATION: 18-50 year old, obese (BMI 30-50) men and premenopausal women, chronically sleep deprived, recruited from the Baltimore-Washington metropolitan area. Chronic sleep deprivation will be verified by the use of sleep logs and the use of actigraphy before entry into the study. Secondary causes of sleep deprivation such as insomnia, psychological (depression), and medical conditions associated with poor sleep quality (including obstructive sleep apnea) will be exclusionary criteria. DESIGN: This is a randomized, 12-month duration, comparison-controlled clinical trial of an extension of sleep up to approximately 7 hours and 30 minutes (Intervention Group) or continuation of habitual short sleep schedule (Comparison Group). The proposed treatment is an educational and behavioral intervention aimed at increasing sleep in a non-pharmacological fashion. The main analysis of the study will be to determine if additional sleep will result in a significant difference in body weight at the end of 12 months between the Intervention Group and the Compariso
Interventions
- PROCEDURE Increase sleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2005-11 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261898
The ClinicalTrials.gov registry entry for NCT00261898 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 239 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 1 intervention - of which Increase sleep is the first listed.
NCT00261898 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00261898 about?
NCT00261898 is a clinical study titled "Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity". OBJECTIVE: Obesity and chronic sleep deprivation have both become increasingly pervasive medical problems in recent years. The prevalence of adult obesity has doubled over the past 30 years and continues to increase. In addition, industrial societies attach an economic value to maximizing the waking...
What is the current status of trial NCT00261898?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2005-11. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00261898?
The interventions under investigation include: Increase sleep (PROCEDURE).
Who is sponsoring clinical trial NCT00261898?
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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