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Sleep Timing and Insulin Resistance in Adolescents With Obesity

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ClinicalTrials.gov Identifier: NCT02585830
Recruitment Status : Completed
First Posted : October 23, 2015
Results First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Obesity

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents
Actual Study Start Date : October 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adolescents with obesity
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585830


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Stacey L Simon, PhD University of Colorado Denver & Children's Hospital Colorado
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02585830    
Other Study ID Numbers: 15-0739
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2015    Key Record Dates
Results First Posted: February 19, 2020
Last Update Posted: February 19, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases