Insulin SensitivitySUNRISENCT03500458
Impact of Sleep Extension in Adolescents
A study testing Sleep Extension in people with Insulin Sensitivity and Sleep, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Sleep, Dietary Habits
- What is being tested?
- Sleep Extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school students between the age of 14-19 years
- have typically insufficient sleep, defined by ≤ 7 hours per night on school days
- BMI 5th-84th percentile for age and sex
- habitually sedentary (< 3 hours of regular physical activity per week)
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Who cannot join
- Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
- regular use of melatonin or other sleep aids
- a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
- Type 2 diabetes or prediabetes
- IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
- teens not enrolled in a traditional high school academic program (e.g., home school students)
- schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
- travel across more than two time zones in the 2 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).
- Conditions
- Insulin Sensitivity, Sleep, Dietary Habits
- Being tested
- Sleep Extension
- Medical subject headings
- Insulin Resistance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
Participants will be asked to increase time in bed at least 1 hour more than baseline
| Study group | Role | What they receive |
|---|---|---|
| Typical Sleep | No intervention | All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule. |
| Sleep Extension | Experimental | Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation). Receives: Behavioral: Sleep Extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
Measured: 2 weeks after Baseline and 7 weeks after Baseline
Change in Sleep Duration & Timing
Assessed three times with a wrist-worn Actigraphy
Measured: At Baseline, 1 week after Baseline, and 6 weeks after Baseline
Change in Physical activity
Assessed three times with a triaxial thigh-worn ActivPal
Measured: At Baseline, 1 week after Baseline and 6 weeks after Baseline
Change in Dietary Intake
Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.
Measured: 1 week after Baseline and 6 weeks after Baseline
Secondary outcomes (2)
Change in glycemic variability
Assessed two times with a continuous glucose monitor
Measured: 2 weeks after Baseline and 7 weeks after Baseline
MTNR1B rs10830963 SNP
Genotyping will be conducted on saliva samples
Measured: 2 weeks after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Oct 2018
- Primary completion31 May 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Simon, PhD, Principal investigator, Children's Hospital Colorado and University of Colorado Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500458
- Sponsor's protocol ID
- 17-2095
- Other IDs
- K23DK117021, R03DK131225
- Acronym
- SUNRISE
- Status last verified
- Sep 2024
- First submitted
- 9 Apr 2018
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
- ClinicalTrials.gov ID
- NCT03500458
- Acronym / sponsor ID
- SUNRISE / 17-2095
- Conditions
- Insulin Sensitivity, Sleep, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Sleep | No intervention | –All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule. |
| Sleep Extension | Experimental | Behavioral: Sleep ExtensionParticipants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation). |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- High school students between the age of 14-19 years
- have typically insufficient sleep, defined by ≤ 7 hours per night on school days
- BMI 5th-84th percentile for age and sex
- habitually sedentary (< 3 hours of regular physical activity per week)
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Key exclusion criteria (8 listed)
- Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
- regular use of melatonin or other sleep aids
- a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
- Type 2 diabetes or prediabetes
- IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ExtensionParticipants will be asked to increase time in bed at least 1 hour more than baseline | Behavioural | Sleep Extension |
Primary outcome
Change in Insulin Sensitivity
Time frame: 2 weeks after Baseline and 7 weeks after Baseline
Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
Change in Sleep Duration & Timing
Time frame: At Baseline, 1 week after Baseline, and 6 weeks after Baseline
Assessed three times with a wrist-worn Actigraphy
Change in Physical activity
Time frame: At Baseline, 1 week after Baseline and 6 weeks after Baseline
Assessed three times with a triaxial thigh-worn ActivPal
Change in Dietary Intake
Time frame: 1 week after Baseline and 6 weeks after Baseline
Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.
2 secondary outcomes
Change in glycemic variability
Time frame: 2 weeks after Baseline and 7 weeks after Baseline
MTNR1B rs10830963 SNP
Time frame: 2 weeks after Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Insulin Sensitivity
Active, not recruiting
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
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Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
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Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Simon, PhD principal investigator
Children's Hospital Colorado and University of Colorado Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension in people with Insulin Sensitivity and Sleep, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Sensitivity (time frame: 2 weeks after Baseline and 7 weeks after Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.