Impact of Yo-Yo Sleep on Cardiometabolic Health

Obesity Clinical Trial

Official title:

Impact of Yo-Yo Sleep on Cardiometabolic Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880758
• Other study ID #: AAAU3694
• Secondary ID: R35HL155670
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: June 2028

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Marie-Pierre St-Onge, PhD
• Phone: 212-305-9549
• Email: ms2554[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Obesity

Intervention

Behavioral:
• Intermittent Short Sleep (ISS)
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.
• Social Jetlag (SJL)
2-hour delayed sleep timing.
• Sustained Adequate Sleep (SAS)
Goal of =7 hours of sleep/night with 8 hours of time in bed (TIB).

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Icahn School of Medicine at Mount Sinai, National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Plasma Glucose	Insulin resistance will be assessed by measuring fasting plasma glucose levels.	Up to 4 weeks
Primary	Insulin Level	Insulin resistance will be assessed by measuring insulin levels.	Up to 4 weeks
Primary	Morning Systolic and Diastolic Blood Pressure	Ambulatory blood pressure will be measured.	Up to 4 weeks
Primary	Evening Systolic and Diastolic Blood Pressure	Ambulatory blood pressure will be measured.	Up to 4 weeks
Primary	Fat mass	Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.	Up to 4 weeks
Secondary	Low-density Lipoprotein (LDL) Level	Lipid panel will be assessed.	Up to 4 weeks
Secondary	High-density Lipoprotein (HDL) Level	Lipid panel will be assessed.	Up to 4 weeks
Secondary	Total Cholesterol Level	Lipid panel will be assessed.	Up to 4 weeks
Secondary	Triglyceride Level	Lipid panel will be assessed.	Up to 4 weeks
Secondary	C-reactive protein (CRP) Level	CRP will be measured as an inflammatory marker.	Up to 4 weeks
Secondary	Interleukin 6 (IL-6)	IL-6 will be measured as an inflammatory marker.	Up to 4 weeks
Secondary	Tumor necrosis factor alpha (TNF-alpha)	TNF-alpha will be measured as an inflammatory marker.	Up to 4 weeks
Secondary	Total daily energy expenditure	Energy expenditure will be measured using doubly-labeled water over 14 days	Baseline and endpoint (4 weeks)
Secondary	Energy Intake	Energy intake will be measured to assess diet quality using daily food records for 7 days.	Baseline and endpoint (4 weeks)
Secondary	Total Ghrelin	Total ghrelin will be assessed using radioimmunoassay (RIA).	2 hours post meal at baseline and endpoint (4 weeks)
Secondary	Serum Leptin	Serum leptin will be measured using a double-antibody RIA.	2 hours post meal at baseline and endpoint (4 weeks)
Secondary	Adiponectin Level	Adiponectin levels will be analyzed using RIA.	Up to 4 weeks
Secondary	Glucagon-like peptide 1 (GLP-1) Level	GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.	2 hours post meal at baseline and endpoint (4 weeks)
Secondary	Change in Nuclear factor kappa B (NFkB) Level	NFkB will be measured to assess endothelial cell inflammation.	Baseline and endpoint (4 weeks)