Sleep Timing and Insulin Resistance in Adolescents With Obesity

NCT ID: NCT02585830

Last Updated: 2020-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stacey L Simon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver & Children's Hospital Colorado

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Simon SL, McWhirter L, Diniz Behn C, Bubar KM, Kaar JL, Pyle L, Rahat H, Garcia-Reyes Y, Carreau AM, Wright KP, Nadeau KJ, Cree-Green M. Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3525-3534. doi: 10.1210/jc.2018-02385.

Reference Type DERIVED
PMID: 30888398 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-0739

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Delayed Sleep Timing in Teens Study
NCT03806296 COMPLETED NA
Light Timing Study
NCT04753190 RECRUITING NA
Home Sleep and Metabolism
NCT02253368 COMPLETED NA
Behavioral Chronotype: Impact on Sleep and Metabolism
NCT03647306 ACTIVE_NOT_RECRUITING NA
Social Determinants of Sleep and Obesity
NCT05698693 RECRUITING EARLY_PHASE1
Sleep Timing and Energy Balance
NCT01866280 COMPLETED NA