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Completed

NCT Number: NCT02585830

Sleep Timing and Insulin Resistance in Adolescents With Obesity

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.

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus/Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dim Light Melatonin Onset and Offset

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2015
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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