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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02585830
Date of registration:	22/10/2015
Prospective Registration:	No
Primary sponsor:	University of Colorado, Denver
Public title:	Sleep Timing and Insulin Resistance in Adolescents With Obesity
Scientific title:	Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents
Date of first enrolment:	October 2015
Target sample size:	25
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02585830
Study type:	Observational
Study design:
Phase:

Countries of recruitment
United States

Contacts

Name:	Stacey L Simon, PhD
Address:
Telephone:
Email:
Affiliation:	University of Colorado Denver & Children's Hospital Colorado

Key inclusion & exclusion criteria

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

Age minimum: 15 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Primary Outcome(s)

Dim Light Melatonin Onset and Offset [Time Frame: 1 day]

Insulin Sensitivity [Time Frame: 3 hours]

Secondary Outcome(s)

Secondary ID(s)

15-0739

UL1TR001082

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	19/02/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02585830

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