Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

Circadian Dysregulation Clinical Trial

Official title:

Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291952
• Other study ID #: R01HL118601
• Status: Completed
• Phase: N/A
• Start date: March 19, 2015
• Est. completion date: August 29, 2018

Study information

• Verified date: March 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.

Description:

Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI between 18.5 and 29.9 kgm-2

• Healthy adults with regular sleep-wake timing

• Non-smokers

• Completion of medical and psychological screening tests

• Able to spend 14 consecutive days in the sleep laboratory

Exclusion Criteria:

• BMI <18.5 or > 29.9 kgm-2

• History of neurological or psychiatric disorder

• History of sleep disorder or regular use of sleep-promoting medication

• Current prescription, herbal, or over-the-counter medication use

• Traveling across 2 or more time zones within past 3 months

• Donating blood within past 8 weeks

• Worked night or rotating shift work within past 3 years

• Hearing impairment

• Drug or alcohol dependency

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation

Intervention

Behavioral:
• Meal schedule

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma leptin levels across sleep/wake cycle	Frequent blood samples	During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Primary	Change in circadian profile of plasma leptin	Frequent blood samples	During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Primary	Change in glucose tolerance	Frequent blood samples before and after standardized meals	During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Primary	Change in circadian profile of plasma glucose levels	Frequent blood samples	During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Primary	Change in plasma insulin levels after standardized test meal	Frequent blood samples before and after standardized meals	During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Primary	Change in circadian profile of plasma insulin levels	Frequent blood samples	During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Secondary	o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol	Core temperature sensor throughout protocol, days 1-14. Frequent blood samples during constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)	Core temperature and frequent blood samples
Secondary	Changes circadian rhythm in resting energy expenditure	Indirect calorimetry	During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Secondary	Change in hunger and appetite, mood, and cognitive performance	Subjective hunger ratings and cognitive tests performed via computer interface	Tests taken throughout the protocol, days 1-14
Secondary	Changes in microbiota, gene expression, epigenetic or proteomic markers	Frequent blood samples and saliva samples	samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)
Secondary	Changes in sleep	Polysomnography	sleep periods following day 1, days 6-7 and days 10-11