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View Clinical Trial (Medical Research Study)
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Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity - NCT00261898-20892 (Clinical Trial 133545)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy133545.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Obesity - Chronic Sleep Deprivation |
| Purpose: |
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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 Comparison Group. In addition, we would like
to establish whether 12 months of additional sleep will result in: a) a decreased prevalence
of metabolic syndrome; and b) changes in the endocrine profile (i.e. inducing changes in
leptin [increase] and ghrelin [decrease] opposite to the changes associated with chronic
sleep deprivation). At the end of the 12-month intervention study (Phase 1, Efficacy
Randomized Phase Study), all participants will be given information about the potential
benefit of more sleep and encouraged to increase sleep time. Health teaching about proper
nutrition and adequate exercise will also be provided at that time to the Intervention and
Comparison Groups. All participants will be evaluated 6 months later to assess the effects
of this intervention in a real-life situation, and offered participation in a three-year
extension with semi-annual visits (Phase 2, Effectiveness 3 Year Follow-Up Phase Study), for
which matched external comparison subjects will also be recruited ad hoc.
OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and
insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine
and anthropometric measures, body composition, various metabolic parameters, food intake,
energy expenditure, and quality of life measures.
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| Study summary: |
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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 Comparison Group. In addition, we would like
to establish whether 12 months of additional sleep will result in: a) a decreased prevalence
of metabolic syndrome; and b) changes in the endocrine profile (i.e. inducing changes in
leptin [increase] and ghrelin [decrease] opposite to the changes associated with chronic
sleep deprivation). At the end of the 12-month intervention study (Phase 1, Efficacy
Randomized Phase Study), all participants will be given information about the potential
benefit of more sleep and encouraged to increase sleep time. Health teaching about proper
nutrition and adequate exercise will also be provided at that time to the Intervention and
Comparison Groups. All participants will be evaluated 6 months later to assess the effects
of this intervention in a real-life situation, and offered participation in a three-year
extension with semi-annual visits (Phase 2, Effectiveness 3 Year Follow-Up Phase Study), for
which matched external comparison subjects will also be recruited ad hoc.
OUTCOME PARAMETERS: body weight, average number of hours of sleep/night, fasting glucose and
insulin, oral glucose tolerance test, leptin, ghrelin, adiponectin, other relevant endocrine
and anthropometric measures, body composition, various metabolic parameters, food intake,
energy expenditure, and quality of life measures. |
| Criteria: |
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- INCLUSION CRITERIA:
18 to 50 year old obese men and premenopausal women
BMI between 29-55
Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular
basis less than or equal to approximately 6-1/2 hours/night by history and objective
devices (wrist activity monitors and sleep logs).
INCLUSION CRITERIA: External comparison subjects for extension of Effectiveness Study must
meet the criteria above.
EXCLUSION CRITERIA:
Diagnosed sleep disorders including:
- Chronic insomnia
- Untreated sleep disordered breathing (sleep apnea at a level of severity [using
standardized criteria for measurement], or diagnosed UARS [upper airway resistance
syndrome] that would impair the ability to increase sleep duration [Intervention
Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in
place for 3 months or more and improves sleep is acceptable).
- Restless leg syndrome or periodic limb movement disorder
- Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep
terrors, sleepwalking, sleep violence)
- Primary bruxism is allowed as long as it does not interfere with the ability to sleep
an additional 90 minutes a night
- Narcolepsy
- Central apnea.
Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months);
currently being enrolled in a weight loss program
Untreated or uncontrolled diabetes
Severe uncontrolled hypertension
Other chronic organ disease diagnosis including:
- COPD
- Chronic cardiac arrhythmia requiring treatments
- Gastro-esophageal disorders associated with sleep-related symptoms.
Medications
- chronic use of prescription or over-the-counter medications known to affect sleep
(e.g., systemic steroids, NSAIDs)
- current anticonvulsant therapy
Chronic fatigue syndrome and fibromyalgia
Acromegaly, hypothyroidism (unless on a stable replacement dose of thyroid hormone),
Cushing disease or other endocrine disorders known to affect sleep
Poorly controlled major depression (subjects who have been on a stable pharmacological
antidepressant treatment for 3 months and are in remission without substantial weight gain
are eligible).
Other current DSM-IV diagnoses, including:
- Eating disorders such as bulimia nervosa and binge eating disorder
- Anxiety disorders such as PTSD and panic attacks
- Mania
- Schizophrenia.
Medication and substance abuse such as excessive alcohol consumption or drug abuse or
dependence that may pose a threat to compliance
Being a rotating worker, shift worker (working evenings or nights), or long distance
commuter (more than approximately 90 minutes each way), traveling frequently outside of
time zone; being in an occupation that may require special vigilance such as driving a
truck, bus, or cab; operating heavy machinery; being a pilot or air traffic controller
Being likely to move to a different geographical area during the study
Having a sleep partner that would make compliance with study requirements difficult
Pregnancy and lactation
Menopause
Chronic excessive caffeine use (habitual intake of more than 500 mg/day)
Any condition that in the opinion of the principal investigator makes study participation
and compliance problematic. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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