Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261898
Status:
TERMINATED
Last Update Posted:
2015-11-04
First Post:
2005-12-04
Brief Title:
Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been terminated Interim analysis of preliminary results indicated the need for protocol re-design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 ie 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 sleepnight 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
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 ie 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 sleepnight 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
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 ie 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 sleepnight 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
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 ie 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 sleepnight 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0036 | None | None | None |