Sleep Timing and Insulin Resistance in Adolescents With Obesity

Completed

• Conditions: Obesity

• Registration Number: NCT02585830
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2020-01-23
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Results First Posted: 2020-02-19
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus/Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States