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Trial Outcomes & Findings for Sleep Timing and Insulin Resistance in Adolescents With Obesity (NCT NCT02585830)

NCT ID: NCT02585830

Last Updated: 2020-02-19

Results Overview

\~1mL saliva was collected at 30- to 60- minute intervals in dim light (\<5 lux in the angle of gaze, approximately the light level of candlelight or civil twilight) from approximately 5pm until noon the next day. Dim light melatonin onset (DLMOn) was defined as the linear interpolated clock time at which evening salivary melatonin concentrations increased and remained above a threshold of 3pg/mL. Melatonin offset (DLMOff) was the linear interpolated clock time at which salivary melatonin concentrations fell below this threshold. Later DLMOn and DLMOff are indicative of a later circadian rhythm.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

1 day

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure
Adolescent Sleep Observation
Home and in-lab observation of sleep and insulin sensitivity
Overall Study
STARTED
25
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Adolescent Sleep Observation
Home and in-lab observation of sleep and insulin sensitivity
Overall Study
Withdrawal by Subject
3

Baseline Characteristics

missing data N =4

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observation
n=25 Participants
Home and in-lab observation
Age, Continuous
16.48 years
STANDARD_DEVIATION 1.09 • n=25 Participants
Sex: Female, Male
Female
15 Participants
n=25 Participants
Sex: Female, Male
Male
10 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=25 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=25 Participants
Race (NIH/OMB)
Asian
0 Participants
n=25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=25 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=25 Participants
Race (NIH/OMB)
White
12 Participants
n=25 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=25 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=25 Participants
Region of Enrollment
United States
25 participants
n=25 Participants
BMI
97.04 percentile
STANDARD_DEVIATION 2.39 • n=21 Participants • missing data N =4

PRIMARY outcome

Timeframe: 1 day

\~1mL saliva was collected at 30- to 60- minute intervals in dim light (\<5 lux in the angle of gaze, approximately the light level of candlelight or civil twilight) from approximately 5pm until noon the next day. Dim light melatonin onset (DLMOn) was defined as the linear interpolated clock time at which evening salivary melatonin concentrations increased and remained above a threshold of 3pg/mL. Melatonin offset (DLMOff) was the linear interpolated clock time at which salivary melatonin concentrations fell below this threshold. Later DLMOn and DLMOff are indicative of a later circadian rhythm.

Outcome measures

Outcome measures
Measure
Observation
n=22 Participants
Home and in-lab observation
Dim Light Melatonin Onset and Offset
Dim Light Melatonin Onset
21.33 decimal hours
Standard Deviation 1.47
Dim Light Melatonin Onset and Offset
Dim Light Melatonin Offset
8.32 decimal hours
Standard Deviation 1.09

PRIMARY outcome

Timeframe: 3 hours

Population: 1 participant with missing data

After an overnight fast, participants completed an oral glucose tolerance test (OGTT) in the morning. Participants consumed a 75g dextrose drink and serum for glucose and insulin concentrations were collected at baseline and every 30 minutes for 3 hours. The homeostatic model assessment for insulin resistance (HOMA-IR) was calculated as \[fasting insulin (μU/ml) x fasting glucose (mmol/l)\] / 22.5); lower HOMA-IR indicates better insulin sensitivity. The Matsuda Index was calculated as √10,000 / \[\[fasting insulin (μU/ml) x fasting glucose (mmol/l)\] x \[mean OSTT insulin (μU/ml) x mean OSTT glucose (mmol/l)\]\]; high Matsuda Index indicates better insulin sensitivity.

Outcome measures

Outcome measures
Measure
Observation
n=21 Participants
Home and in-lab observation
Insulin Sensitivity
Homeostatic Model Assessment (HOMA-IR)
2.9 units on a scale
Standard Deviation 2.01
Insulin Sensitivity
Matsuda Index
4.93 units on a scale
Standard Deviation 2.75

Adverse Events

Observation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stacey L. Simon

University of Colorado Anschutz Medical Campus

Phone: 720-777-5681

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place