Sleep Timing and Insulin Resistance in Adolescents With Obesity

NCT02585830 | Completed Results

• 2 other identifiers: 15-0739UL1TR001082
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 √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.

  3 hours

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with obesity

You may qualify if:

• High school students between the ages of 15-19
• BMI \> 90th percentile
• Tanner stage 2 or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

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

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 30888398 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stacey L. Simon
• Organization: University of Colorado Anschutz Medical Campus

stacey.simon@childrenscolorado.org

720-777-5681

Study Officials

• Stacey L Simon, PhD

  University of Colorado Denver & Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Locations

US (1)