Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00261898
  Purpose

This study will test whether people can change the number of hours they sleep at night and if such an increase in sleep affects their body weight. It will examine whether the number of hours of sleep relate to body weight, the amount of body fat and the level of hormones that help to control appetite.

People between 18 and 50 years of age who sleep less than 6 hours at night and who are obese may be eligible for this study. Each candidate is screened with a medical history and physical examination, psychological interview, blood and urine tests, electrocardiogram and questionnaire about sleep, mood, physical activity and level of sleepiness and appetite. For two weeks, participants will keep sleep and exercise diaries and wear a wrist device (activity watch) that measures how much they move around throughout the day and night. They keep a food diary for three days and then are admitted to the hospital for a sleep study. For this test, electrodes are attached to the subject's chest, chin, scalp and skin near the eyes. A band is placed around the chest, a small device is placed near a nostril, and a clip is placed on the index finger. These devices are used to record information about breathing, sleep stages, electrical activity in the brain and heart, and blood oxygen levels. A video camera records the subject's movements.

Participants are randomly assigned to one of two groups. Over the 12-month study, group A subjects increase their amount of night-time sleep up to a limit of 7.5 hours a night; group B subjects continue to sleep the same amount they have been sleeping in the past 6 months. Plans are devised for group A to increase their sleep time and for group B to continue getting the same amount of sleep they have in the past. All subjects undergo the following tests and procedures:

  • Baseline visit - Month 0 (overnight hospital stay): At the start of the study, participants have blood and urine tests, their sleep, exercise and food diaries are reviewed, and their body measurements are taken. They have various tests that measure their body fat and lean muscle tissue, the rate at which their body burns calories, and their level of physical conditioning. They answer questionnaires about their appetite, sleepiness, mood, anxiety, pain, and health status and are tested for diabetes and daytime sleepiness. Between visits, subjects fill out exercise and sleep diaries, wear the activity watch, record their weight and blood pressure, and wear a pedometer to record a daily count of the steps they take.
  • Interim visits - Months 1, 2, 4, 6, 8 and 10: Participants have blood tests and their sleep and exercise diaries, food intake from the previous day, blood pressure and weight measurements, pedometer step records and activity records from the activity watches are reviewed. They are asked about their sleep, mood and anxiety, and they rate their appetite and sleepiness.
  • End-point visit - Month 12 (2-day hospital stay): Participants repeat the sleep study and the tests done at the baseline visit. They are given information about a healthy diet, exercise and sleep. They are asked to exercise regularly, eat a healthy balanced diet, continue to wear the pedometer, complete the sleep and exercise diaries for one week of each month, and take monthly weight and blood pressure measurements. Group A subjects are asked to continue sleeping as much as possible up to 7.5 hours a night; group B subjects are given a plan to try to increase their sleep up to 7.5 hours a night.
  • Follow-up visit - Month 18 (2-day hospital stay): Participants repeat several, but not all, of the tests and procedures they had at the 0- and 12-month visits, have another sleep study, and review the sleep, exercise, and food diaries for the last 6 months.

Condition Intervention Phase
Obesity
Chronic Sleep Deprivation
Procedure: Increase sleep
Phase II

MedlinePlus related topics: Exercise and Physical Fitness Obesity
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 450
Study Start Date: November 2005
Intervention Details:
    Procedure: Increase sleep
    N/A
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261898

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 060036, 06-DK-0036
Study First Received: December 4, 2005
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00261898  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Sleep Deprivation
Obesity
Metabolic Syndrome
Hormones
Public Health
Obesity
Overweight
Sleep
Sleep Deprivation

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Mental Disorders
Neurologic Manifestations
Sleep Disorders
Dyssomnias
Nutrition Disorders
Overnutrition
Overweight
Sleep Deprivation

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009