Sleep Timing and Insulin Resistance in Adolescents With Obesity

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT02585830
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.

Condition or Disease	Intervention/Treatment	Phase
Obesity

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Outcome Measures

Primary Outcome Measures

1. Dim Light Melatonin Onset and Offset [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.

2. Insulin Sensitivity [3 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• High school students between the ages of 15-19

• BMI > 90th percentile

• Tanner stage 2 or greater

Exclusion Criteria:

• Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics)

• Regular use of melatonin or sleep aids

• A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c > 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding

• IQ < 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes)

• Not enrolled in a traditional high school academic program (e.g., home school students)

• Night shift employment

• Travel across more than 2 time zones in the month prior to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus/Children's Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Stacey L Simon, PhD, University of Colorado Denver & Children's Hospital Colorado

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 22, 2016

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02585830
• Other Study ID Numbers: 15-0739; UL1TR001082
• First Posted: Oct 23, 2015
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Obesity; Insulin Resistance

Study Results

Participant Flow

Arm/Group Title	Adolescent Sleep Observation
Arm/Group Description	Home and in-lab observation of sleep and insulin sensitivity
Period Title: Overall Study
STARTED	25
COMPLETED	22
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Observation
Arm/Group Description	Home and in-lab observation
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.48 (1.09)
Sex: Female, Male (Count of Participants)
Female	15 60%
Male	10 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 72%
Not Hispanic or Latino	7 28%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 24%
White	12 48%
More than one race	6 24%
Unknown or Not Reported	1 4%
Region of Enrollment (participants) [Number]
United States	25 100%
BMI (percentile) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentile]	97.04 (2.39)

Outcome Measures

1. Primary Outcome

Title	Dim Light Melatonin Onset and Offset
Description	~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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Observation
Arm/Group Description	Home and in-lab observation
Measure Participants	22
Dim Light Melatonin Onset	21.33 (1.47)
Dim Light Melatonin Offset	8.32 (1.09)

2. Primary Outcome

Title	Insulin Sensitivity
Description	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.
Time Frame	3 hours

Outcome Measure Data

Analysis Population Description

1 participant with missing data

Arm/Group Title	Observation
Arm/Group Description	Home and in-lab observation
Measure Participants	21
Homeostatic Model Assessment (HOMA-IR)	2.9 (2.01)
Matsuda Index	4.93 (2.75)

Adverse Events

Time Frame	1 month
Arm/Group Title	Observation
Arm/Group Description	Home and in-lab observation
All Cause Mortality
	Observation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	Observation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	Observation
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.