Sleep Timing and Insulin Resistance in Adolescents With Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585830
• Other study ID #: 15-0739
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: October 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus/Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dim Light Melatonin Onset and Offset	~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.	1 day
Primary	Insulin Sensitivity	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 v10,000 / [[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.	3 hours