Health TrialsbyHealthPanel

Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents

ConditionsOverweight AdolescentsSleepInsulin Sensitivity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorUniversity of Colorado, Denver

About this trial

Many teenagers get too little and late timed sleep. High body weight and diabetes are increasing in teenagers as well. This study plans to learn more about whether improving sleep habits can help improve how the body regulates blood sugar and energy use in teenagers who have higher body weight. To answer this question, the investigators plan to enroll teenagers who get \<7 hours of sleep on school nights and measure changes in blood sugars and energy use after two weeks of typical sleep (sleeping on their normal school schedule) and two weeks of a sleep intervention that includes spending longer time in bed at night, melatonin, and morning light.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High school students between 14-19 years

Overweight/obesity (BMI >85% for age and sex)

Have habitually insufficient sleep, defined as ≤ 7 hours per night on school days

Habitually inactive (≤ 3 h of physical activity reported per week)

Disqualifiers

Reported diagnosis of sleep disorder (e.g., insomnia, obstructive sleep apnea)

Medical comorbidities that impact sleep or insulin sensitivity (e.g., diabetes [based on history or screening HbA1c])

Regular use of medications affecting sleep or insulin sensitivity (e.g., stimulants, sleep aids, systemic steroids, insulin sensitizers, GLP-1 agonists)

IQ<70 or severe mental illness that may impact sleep or study participation (e.g., schizophrenia), eating disorder, or active suicidal ideation

Trial design

Design model

Crossover

Treatments tested in this trial

  • Circadian/Sleep (C/S)

    Behavioral

    1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Typical SleepNo intervention 0 interventions
Group B: Circadian/Sleep (C/S) ConditionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Insulin sensitivity

Matsuda Index will be calculated from a mixed meal tolerance test (MMTT); higher values indicate better insulin sensitivity.

Time frame
Assessed at 2 weeks following each condition

Secondary outcomes

1

Total daily energy expenditure (TDEE)

Assessed with doubly labeled water. Higher values indicate greater energy expenditure

Time frame
Assessed for two weeks during each condition
2

Average daily caloric intake (kcal/day)

Calculated from photographic diet diaries. Higher kcal indicates greater caloric intake.

Time frame
Measured for 3 days during each condition

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: