Overweight AdolescentsRESTNCT07618117
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
A study testing Circadian/Sleep (C/S) in people with Overweight Adolescents and Sleep, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Overweight Adolescents, Sleep, Insulin Sensitivity
- What is being tested?
- Circadian/Sleep (C/S)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Who cannot join
- 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
- Schedules that would preclude participants from adhering to the sleep schedules (e.g., night-shift employment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Angel Arias, BS, 720-682-8925, RESTStudy@childrenscolorado.org
Stacey Simon, PhD
About this study
Official title: Mitigating Cardiometabolic Risk by Improving Sleep Health and Circadian Timing in Adolescents With Overweight/Obesity
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.
- Conditions
- Overweight Adolescents, Sleep, Insulin Sensitivity
- Being tested
- Circadian/Sleep (C/S)
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian/Sleep (C/S)Behavioural
1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking
| Study group | Role | What they receive |
|---|---|---|
| Typical Sleep | No intervention | Habitual sleep schedule |
| Circadian/Sleep (C/S) Condition | Experimental | 1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking Receives: Behavioral: Circadian/Sleep (C/S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Matsuda Index will be calculated from a mixed meal tolerance test (MMTT); higher values indicate better insulin sensitivity.
Measured: Assessed at 2 weeks following each condition
Secondary outcomes (2)
Total daily energy expenditure (TDEE)
Assessed with doubly labeled water. Higher values indicate greater energy expenditure
Measured: Assessed for two weeks during each condition
Average daily caloric intake (kcal/day)
Calculated from photographic diet diaries. Higher kcal indicates greater caloric intake.
Measured: Measured for 3 days during each condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start20 Oct 2026
- Primary completion15 Jun 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey L Simon, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618117
- Sponsor's protocol ID
- 25-1531
- Other IDs
- 1R01DK142774-01
- Acronym
- REST
- Status last verified
- Nov 2026
- First submitted
- 13 May 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interests. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cardiometabolic Risk by Improving Sleep Health and Circadian Timing in Adolescents With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT07618117
- Acronym / sponsor ID
- REST / 25-1531
- Conditions
- Overweight Adolescents, Sleep, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 1 Jun 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Sleep | No intervention | –Habitual sleep schedule |
| Circadian/Sleep (C/S) Condition | Experimental | Behavioral: Circadian/Sleep (C/S)1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
- Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Key exclusion criteria (5 listed)
- 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
- Schedules that would preclude participants from adhering to the sleep schedules (e.g., night-shift employment)
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 |
|---|---|---|
| Circadian/Sleep (C/S)1h additional time in bed, melatonin 2h before bedtime, and 30 minutes bright light after waking | Behavioural | Circadian/Sleep (C/S) Condition |
Primary outcome
Insulin sensitivity
Time frame: Assessed at 2 weeks following each condition
Matsuda Index will be calculated from a mixed meal tolerance test (MMTT); higher values indicate better insulin sensitivity.
2 secondary outcomes
Total daily energy expenditure (TDEE)
Time frame: Assessed for two weeks during each condition
Average daily caloric intake (kcal/day)
Time frame: Measured for 3 days during each condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interests. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Stacey L Simon principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian/Sleep (C/S) in people with Overweight Adolescents 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 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey L Simon, PhD (720-777-5681, stacey.simon@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Assessed at 2 weeks following each condition). 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 5 Nov 2026.