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ObesityPhase 2NCT00261898

Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

A Phase 2 study testing Increase sleep in people with Obesity and Chronic Sleep Deprivation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obesity, Chronic Sleep Deprivation
What is being tested?
Increase sleep
Type of treatment
Surgery or procedure
How many people
239 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 34Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read more

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.

Read the 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 29-55) 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.

The study was terminated early for reasons of apparent futility of continuing accrual of participants according to the original study plan. The decision was based on independent analysis of data acquired during the initial feasibility phase and from interim analysis of early results that failed to document objectively the achievement of substantive and meaningful differences between experimental and control groups with respect to amounts of sleep extension, changes in metabolic parameters, or changes in weight. Feasibilities of achieving objective and substantive differences in these parameters were integral to the methodology of the original study plan and required to meet the statistical power calculations for the controlled trial.

Being tested
Increase sleep
Keywords
Sleep Deprivation, Obesity, Metabolic Syndrome, Hormones, Public Health, Overweight, Sleep
Medical subject headings
Obesity, Sleep Deprivation, Metabolic Syndrome, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increase sleepProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2013
  4. Study completionJun 2013

Why it stopped: This study has been terminated. (Interim analysis of preliminary results indicated the need for protocol re-design).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00261898
Sponsor's protocol ID
060036
Other IDs
06-DK-0036
Status last verified
Nov 2015
First submitted
4 Dec 2005
Last updated
4 Nov 2015
Results posted
No

Publications

  • Cizza G, Skarulis M, Mignot E. A link between short sleep and obesity: building the evidence for causation. Sleep. 2005 Oct;28(10):1217-20. doi: 10.1093/sleep/28.10.1217. No abstract available.

    PubMed 16295203

  • Cizza G, Romagni P, Lotsikas A, Lam G, Rosenthal NE, Chrousos GP. Plasma leptin in men and women with seasonal affective disorder and in healthy matched controls. Horm Metab Res. 2005 Jan;37(1):45-8. doi: 10.1055/s-2005-861033.

    PubMed 15702439

  • Bray GA. Medical consequences of obesity. J Clin Endocrinol Metab. 2004 Jun;89(6):2583-9. doi: 10.1210/jc.2004-0535.

    PubMed 15181027

  • Gangwisch JE, Malaspina D, Boden-Albala B, Heymsfield SB. Inadequate sleep as a risk factor for obesity: analyses of the NHANES I. Sleep. 2005 Oct;28(10):1289-96. doi: 10.1093/sleep/28.10.1289.

    PubMed 16295214

  • Hasler G, Buysse DJ, Klaghofer R, Gamma A, Ajdacic V, Eich D, Rossler W, Angst J. The association between short sleep duration and obesity in young adults: a 13-year prospective study. Sleep. 2004 Jun 15;27(4):661-6. doi: 10.1093/sleep/27.4.661.

    PubMed 15283000

  • Spiegel K, Tasali E, Penev P, Van Cauter E. Brief communication: Sleep curtailment in healthy young men is associated with decreased leptin levels, elevated ghrelin levels, and increased hunger and appetite. Ann Intern Med. 2004 Dec 7;141(11):846-50. doi: 10.7326/0003-4819-141-11-200412070-00008.

    PubMed 15583226

  • Wehr TA. Effect of seasonal changes in daylength on human neuroendocrine function. Horm Res. 1998;49(3-4):118-24. doi: 10.1159/000023157.

    PubMed 9550111

  • Cizza G, Piaggi P, Rother KI, Csako G; Sleep Extension Study Group. Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies. PLoS One. 2014 Aug 20;9(8):e104176. doi: 10.1371/journal.pone.0104176. eCollection 2014.

    PubMed 25141012

  • Cizza G, Marincola P, Mattingly M, Williams L, Mitler M, Skarulis M, Csako G. Treatment of obesity with extension of sleep duration: a randomized, prospective, controlled trial. Clin Trials. 2010 Jun;7(3):274-85. doi: 10.1177/1740774510368298. Epub 2010 Apr 27.

    PubMed 20423926

  • Lucassen EA, Piaggi P, Dsurney J, de Jonge L, Zhao XC, Mattingly MS, Ramer A, Gershengorn J, Csako G, Cizza G; Sleep Extension Study Group. Sleep extension improves neurocognitive functions in chronically sleep-deprived obese individuals. PLoS One. 2014 Jan 15;9(1):e84832. doi: 10.1371/journal.pone.0084832. eCollection 2014.

    PubMed 24482677

  • Cizza G, Piaggi P, Lucassen EA, de Jonge L, Walter M, Mattingly MS, Kalish H, Csako G, Rother KI; Sleep Extension Study Group. Obstructive sleep apnea is a predictor of abnormal glucose metabolism in chronically sleep deprived obese adults. PLoS One. 2013 May 29;8(5):e65400. doi: 10.1371/journal.pone.0065400. Print 2013.

    PubMed 23734252

  • Lucassen EA, Zhao X, Rother KI, Mattingly MS, Courville AB, de Jonge L, Csako G, Cizza G; Sleep Extension Study Group. Evening chronotype is associated with changes in eating behavior, more sleep apnea, and increased stress hormones in short sleeping obese individuals. PLoS One. 2013;8(3):e56519. doi: 10.1371/journal.pone.0056519. Epub 2013 Mar 6.

    PubMed 23483886

  • de Jonge L, Zhao X, Mattingly MS, Zuber SM, Piaggi P, Csako G, Cizza G; NIDDK Sleep Extension Study Group. Poor sleep quality and sleep apnea are associated with higher resting energy expenditure in obese individuals with short sleep duration. J Clin Endocrinol Metab. 2012 Aug;97(8):2881-9. doi: 10.1210/jc.2011-2858. Epub 2012 Jun 11.

    PubMed 22689694

  • Knutson KL, Galli G, Zhao X, Mattingly M, Cizza G; NIDDK Sleep Extension Study. No association between leptin levels and sleep duration or quality in obese adults. Obesity (Silver Spring). 2011 Dec;19(12):2433-5. doi: 10.1038/oby.2011.248. Epub 2011 Jul 28.

    PubMed 21799479

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Increase sleep in people with Obesity and Chronic Sleep Deprivation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study has been terminated. (Interim analysis of preliminary results indicated the need for protocol re-design).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00261898, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.

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