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Impact of Yo-Yo Sleep on Cardiometabolic Health

Primary Purpose

Cardiometabolic Syndrome, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Short Sleep (ISS)
Social Jetlag (SJL)
Sustained Adequate Sleep (SAS)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiometabolic Syndrome focused on measuring Sleep, Circadian Rhythms, Cardiometabolic Health

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18 to 49 years BMI 20-29.9 kg/m2 Habitually sleeping 7-9 hours/night without sleep aids or naps Exclusion Criteria: Sleep disorders Psychiatric disorders (including eating disorders) and seasonal affective disorder Pregnancy (current/prior year) Breastfeeding Smokers (Any cigarette smoking or ex-smokers <3years) Diabetes Elevated blood pressure, taking beta-blockers Individuals taking anti-coagulants or anti-platelets Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure. Travel across time zones; shift work (non-traditional hours)

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Stable Adequate Sleep (SAS)

ISS_Alone

ISS_SJL

Arm Description

Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.

Intermittent short sleep (ISS) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with advanced bedtimes and delayed wake times

Intermittent short sleep with short jetlag (SJL) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with constant bedtimes and delayed wake times

Outcomes

Primary Outcome Measures

Fasting Plasma Glucose
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Insulin Level
Insulin resistance will be assessed by measuring insulin levels.
Morning Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Evening Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Fat mass
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.

Secondary Outcome Measures

Low-density Lipoprotein (LDL) Level
Lipid panel will be assessed.
High-density Lipoprotein (HDL) Level
Lipid panel will be assessed.
Total Cholesterol Level
Lipid panel will be assessed.
Triglyceride Level
Lipid panel will be assessed.
C-reactive protein (CRP) Level
CRP will be measured as an inflammatory marker.
Interleukin 6 (IL-6)
IL-6 will be measured as an inflammatory marker.
Tumor necrosis factor alpha (TNF-alpha)
TNF-alpha will be measured as an inflammatory marker.
Total daily energy expenditure
Energy expenditure will be measured using doubly-labeled water over 14 days
Energy Intake
Energy intake will be measured to assess diet quality using daily food records for 7 days.
Total Ghrelin
Total ghrelin will be assessed using radioimmunoassay (RIA).
Serum Leptin
Serum leptin will be measured using a double-antibody RIA.
Adiponectin Level
Adiponectin levels will be analyzed using RIA.
Glucagon-like peptide 1 (GLP-1) Level
GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.
Change in Nuclear factor kappa B (NFkB) Level
NFkB will be measured to assess endothelial cell inflammation.

Full Information

First Posted
May 17, 2023
Last Updated
August 15, 2023
Sponsor
Columbia University
Collaborators
Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05880758
Brief Title
Impact of Yo-Yo Sleep on Cardiometabolic Health
Official Title
Impact of Yo-Yo Sleep on Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 8 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).
Detailed Description
A large portion of the U.S. adult population reports insufficient sleep on a nightly basis. It has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. However, sleep patterns in real life are not consistent over weeks. Individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. The differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. A drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. However, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. Available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (SR) levels. But these studies are short, usually involving only one cycle of SR followed by recovery sleep, and fail to use appropriate and robust statistical methods. Therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. A secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome, Obesity
Keywords
Sleep, Circadian Rhythms, Cardiometabolic Health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3-arm, parallel study design
Masking
Outcomes Assessor
Masking Description
Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stable Adequate Sleep (SAS)
Arm Type
Active Comparator
Arm Description
Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.
Arm Title
ISS_Alone
Arm Type
Experimental
Arm Description
Intermittent short sleep (ISS) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with advanced bedtimes and delayed wake times
Arm Title
ISS_SJL
Arm Type
Experimental
Arm Description
Intermittent short sleep with short jetlag (SJL) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with constant bedtimes and delayed wake times
Intervention Type
Behavioral
Intervention Name(s)
Intermittent Short Sleep (ISS)
Other Intervention Name(s)
ISS
Intervention Description
Restricted sleep duration of <5.5 h/night for 5 nights (SR) followed by 2 nights of 9.5 hours of time in bed (TIB) (recover sleep) each week.
Intervention Type
Behavioral
Intervention Name(s)
Social Jetlag (SJL)
Other Intervention Name(s)
SJL
Intervention Description
2-hour delayed sleep timing.
Intervention Type
Behavioral
Intervention Name(s)
Sustained Adequate Sleep (SAS)
Other Intervention Name(s)
SAS
Intervention Description
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Primary Outcome Measure Information:
Title
Fasting Plasma Glucose
Description
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Time Frame
Up to 8 weeks
Title
Insulin Level
Description
Insulin resistance will be assessed by measuring insulin levels.
Time Frame
Up to 8 weeks
Title
Morning Systolic and Diastolic Blood Pressure
Description
Ambulatory blood pressure will be measured.
Time Frame
Up to 8 weeks
Title
Evening Systolic and Diastolic Blood Pressure
Description
Ambulatory blood pressure will be measured.
Time Frame
Up to 8 weeks
Title
Fat mass
Description
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Low-density Lipoprotein (LDL) Level
Description
Lipid panel will be assessed.
Time Frame
Up to 8 weeks
Title
High-density Lipoprotein (HDL) Level
Description
Lipid panel will be assessed.
Time Frame
Up to 8 weeks
Title
Total Cholesterol Level
Description
Lipid panel will be assessed.
Time Frame
Up to 8 weeks
Title
Triglyceride Level
Description
Lipid panel will be assessed.
Time Frame
Up to 8 weeks
Title
C-reactive protein (CRP) Level
Description
CRP will be measured as an inflammatory marker.
Time Frame
Up to 8 weeks
Title
Interleukin 6 (IL-6)
Description
IL-6 will be measured as an inflammatory marker.
Time Frame
Up to 8 weeks
Title
Tumor necrosis factor alpha (TNF-alpha)
Description
TNF-alpha will be measured as an inflammatory marker.
Time Frame
Up to 8 weeks
Title
Total daily energy expenditure
Description
Energy expenditure will be measured using doubly-labeled water over 14 days
Time Frame
Baseline and endpoint (8 weeks)
Title
Energy Intake
Description
Energy intake will be measured to assess diet quality using daily food records for 7 days.
Time Frame
Baseline and endpoint (8 weeks)
Title
Total Ghrelin
Description
Total ghrelin will be assessed using radioimmunoassay (RIA).
Time Frame
2 hours post meal at baseline and endpoint (8 weeks)
Title
Serum Leptin
Description
Serum leptin will be measured using a double-antibody RIA.
Time Frame
2 hours post meal at baseline and endpoint (8 weeks)
Title
Adiponectin Level
Description
Adiponectin levels will be analyzed using RIA.
Time Frame
Up to 8 weeks
Title
Glucagon-like peptide 1 (GLP-1) Level
Description
GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.
Time Frame
2 hours post meal at baseline and endpoint (8 weeks)
Title
Change in Nuclear factor kappa B (NFkB) Level
Description
NFkB will be measured to assess endothelial cell inflammation.
Time Frame
Baseline and endpoint (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 to 49 years BMI 20-29.9 kg/m2 Habitually sleeping 7-9 hours/night without sleep aids or naps Exclusion Criteria: Sleep disorders Psychiatric disorders (including eating disorders) and seasonal affective disorder Pregnancy (current/prior year) Breastfeeding Smokers (Any cigarette smoking or ex-smokers <3years) Diabetes Elevated blood pressure, taking beta-blockers Individuals taking anti-coagulants or anti-platelets Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure. Travel across time zones; shift work (non-traditional hours)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Pierre St-Onge, PhD
Phone
212-305-9549
Email
ms2554@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Greiby Mercedes
Phone
646-761-3455
Email
gdm2130@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, PhD
Phone
212-305-9549
Email
ms2554@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, PhD
First Name & Middle Initial & Last Name & Degree
Sanja Jelic, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. HIPAA privacy rule for de-identification of a dataset will be followed before transferring data.
IPD Sharing Time Frame
Data will become available after results of the main aims from the final dataset have been accepted for publication.
IPD Sharing Access Criteria
Contact PI for information on data availability and data sharing.

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Impact of Yo-Yo Sleep on Cardiometabolic Health

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