Circadian Timing, Information Processing and Energy Balance Study

Overweight and Obesity Clinical Trial

— TIME  

Official title:

Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04759755
• Other study ID #: 00117438
• Secondary ID: 1R01HL141706-01A
• Status: Active, not recruiting
• Start date: May 29, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.

Description:

The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.

In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;

• able to read and write in English;

• BMI 25-39.9 (overweight, class one obesity, or class two obesity)

Exclusion Criteria:

• High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;

• Diagnosed with diabetes or HbA1c>7 at screening or taking medications known to affect glucose;

• History of cognitive or neurological disorders;

• Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;

• Unstable or serious medical illness;

• Overnight shift work or travel over 2 time zones in the past 2 months;

• Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;

• Current smoking;

• Daily caffeine intake >300 mg;

• Pregnant or lactating;

• Currently on a restrictive of special diet.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Utah	National Heart, Lung, and Blood Institute (NHLBI), Rush University Medical Center, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	Height and weight will be measured at screening and 1 year follow-up	12 months
Other	Metabolic control	HbA1c will be measured at screening and 12-month follow-up	12 months
Primary	Insulin resistance	Measured by a frequently sampled IV glucose tolerance test	Baseline
Secondary	Eating behaviors	Healthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)	12 months
Secondary	Delay discounting	Measured by a 10 item adjusting delay discounting measure	Baseline