Status:
TERMINATED
Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Chronic Sleep Deprivation
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 contin...
Detailed Description
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 contin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00261898
Start Date
November 1 2005
End Date
June 1 2013
Last Update
November 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892