SleepNCT03754036
Sleep Extension and Insulin Sensitivity in Adolescents
A study testing Sleep manipulation in people with Sleep, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical relevance given the high prevalence of sleep deprivation in this population and the accumulating body of evidence indicating that having a good night's sleep is… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2019to 12 Dec 2021
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between the ages of 13 and 18 with obesity (body mass index greater than the 95th percentile) and dyslipidemia (total cholesterol ≥ 200 mg/dL; low-density lipoprotein cholesterol ≥ 130 mg/dL; non-high-density lipoprotein ≥ 145 mg/dL; triglycerides ≥ 130 mg/dL; and high-density lipoprotein < 40 mg/dL)
- Adolescents who report between 6.5-8 hours of sleep per night will be eligible to ensure that adolescents can extend and restrict sleep duration without reaching a ceiling for what can be achieved (i.e. 8-10 hours/night of sleep is recommended at this age) while limiting excessive sleep deprivation
Who cannot join
- History of a chronic medical or psychiatric condition
- Use of medications that could affect sleep or glucose homeostasis (e.g., metformin, thyroid medication, stimulant medication, etc.)
- History of sleep problems (e.g. sleep apnea).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1
About this study
Official title: Effect of Increasing Sleep Duration on Insulin Sensitivity in Adolescents Having Risk Factors for Type 2 Diabetes
BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical relevance given the high prevalence of sleep deprivation in this population and the accumulating body of evidence indicating that having a good night's sleep is important for the prevention of chronic diseases including type 2 diabetes.
OBJECTIVE: To determine if extending sleep duration improves insulin sensitivity in adolescents presenting with risk factors for type 2 diabetes.
Read more
HYPOTHESIS: It was hypothesized that compared with decreasing sleep duration, increasing sleep duration by 1.5 hours over 1 week will improve insulin sensitivity.
METHODS: Using a randomized, counterbalanced, 2-condition crossover design, 30 obese adolescents between 13 and 18 years of age who have insulin resistance will complete the study. Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of at least 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center. Participants will also be compensated for keeping the sleep schedule and daily calls to enhance adherence. The outcome measures will then be compared between both sleep conditions at the end (on day 8 of each study week). The primary outcome measure will be insulin sensitivity as measured by the Matsuda index (total body insulin sensitivity). Secondary outcomes will include the homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, food intake and physical activity. Repeated measures analysis using the mixed model will be used to assess the effect of the two sleep interventions on insulin sensitivity.
RELEVANCE: The study will provide the first robust clinical evidence to determine if increasing sleep duration in youth at risk for type 2 diabetes improves insulin sensitivity. This information will be essential for clinical and public health guidelines for type 2 diabetes prevention among adolescents.
- Conditions
- Sleep
- Being tested
- Sleep manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep manipulationBehavioural
Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension | Experimental | Increase in time in bed of 1.5 hours per night for one week Receives: Behavioral: Sleep manipulation |
| Sleep Restriction | Experimental | Decrease in time in bed of 1.5 hours per night for one week Receives: Behavioral: Sleep manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)
Measured: On day 8 of each sleep condition (2 time points)
Secondary outcomes (4)
Insulin sensitivity
HOMA-IR
Measured: On day 8 of each sleep condition (2 time points)
Blood lipids
HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol
Measured: On day 8 of each sleep condition (2 time points)
Food intake
3-day dietary record
Measured: On days 5, 6 and 7 of each sleep condition (2 time points)
Physical activity level
Minutes per day of moderate-to-vigorous physical activity as assessed by accelerometry
Measured: During each 7-day sleep condition (2 time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start5 Jan 2019
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Model description
- Sleep restriction (-1.5 hours of sleep per day for 1 week) and Sleep extension (+1.5 hours of sleep per day for 1 week)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Philippe Chaput, Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754036
- Sponsor's protocol ID
- 17/63X
- Status last verified
- Jul 2022
- First submitted
- 23 Nov 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dutil C, Podinic I, Walsh JJ, Goldfield GS, Chaput JP. Effect of Sleep Duration Manipulation on Brain-Derived Neurotrophic Factor in Adolescents at Risk for Type 2 Diabetes: A Randomized Crossover Study. J Sleep Res. 2026 May 26:e70375. doi: 10.1111/jsr.70375. Online ahead of print.
PubMed 42192565Dutil C, Podinic I, Featherstone RB, Eaton A, Sadler CM, Goldfield GS, Hadjiyannakis S, Gruber R, Tremblay MS, Prud'homme D, Chaput JP. Sleep and insulin sensitivity in adolescents at risk of type 2 diabetes: the Sleep Manipulation in Adolescents at Risk of Type 2 Diabetes randomized crossover study. Sleep. 2024 May 10;47(5):zsad313. doi: 10.1093/sleep/zsad313.
PubMed 38070132
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increasing Sleep Duration on Insulin Sensitivity in Adolescents Having Risk Factors for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03754036
- Acronym / sponsor ID
- 17/63X
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 27 Nov 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.
BACKGROUND: The influence of sleep extension on glucose homeostasis in adolescents at risk for type 2 diabetes is unknown. This issue is of high clinical relevance given the high prevalence of sleep deprivation in this population and the accumulating body of evidence indicating that having a good night's sleep is important for the prevention of chronic diseases including type 2 diabetes.
OBJECTIVE: To determine if extending sleep duration improves insulin sensitivity in adolescents presenting with risk factors for type 2 diabetes.
HYPOTHESIS: It was hypothesized that compared with decreasing sleep duration, increasing sleep duration by 1.5 hours over 1 week will improve insulin sensitivity.
METHODS: Using a randomized, counterbalanced, 2-condition crossover design, 30 obese adolescents between 13 and 18 years of age who have insulin resistance will complete the study. Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of at least 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center. Participants will also be compensated for keeping the sleep schedule and daily calls to enhance adherence. The outcome measures will then be compared between both sleep conditions at the end (on day 8 of each study week). The primary outcome measure will be insulin sensitivity as measured by the Matsuda index (total body insulin sensitivity). Secondary outcomes will include the homeostasis model assessment of insulin resistance (HOMA-IR), blood lipids, food intake and physical activity. Repeated measures analysis using the mixed model will be used to assess the effect of the two sleep interventions on insulin sensitivity.
RELEVANCE: The study will provide the first robust clinical evidence to determine if increasing sleep duration in youth at risk for type 2 diabetes improves insulin sensitivity. This information will be essential for clinical and public health guidelines for type 2 diabetes prevention among adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sleep restriction (-1.5 hours of sleep per day for 1 week) and Sleep extension (+1.5 hours of sleep per day for 1 week)
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: Sleep manipulationIncrease in time in bed of 1.5 hours per night for one week |
| Sleep Restriction | Experimental | Behavioral: Sleep manipulationDecrease in time in bed of 1.5 hours per night for one week |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents between the ages of 13 and 18 with obesity (body mass index greater than the 95th percentile) and dyslipidemia (total cholesterol ≥ 200 mg/dL; low-density lipoprotein cholesterol ≥ 130 mg/dL; non-high-density lipoprotein ≥ 145 mg/dL; triglycerides ≥ 130 mg/dL; and high-density lipoprotein < 40 mg/dL)
- Adolescents who report between 6.5-8 hours of sleep per night will be eligible to ensure that adolescents can extend and restrict sleep duration without reaching a ceiling for what can be achieved (i.e. 8-10 hours/night of sleep is recommended at this age) while limiting excessive sleep deprivation
Key exclusion criteria (3 listed)
- History of a chronic medical or psychiatric condition
- Use of medications that could affect sleep or glucose homeostasis (e.g., metformin, thyroid medication, stimulant medication, etc.)
- History of sleep problems (e.g. sleep apnea).
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 manipulationParticipants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center. | Behavioural | Sleep Extension, Sleep Restriction |
Primary outcome
Insulin sensitivity
Time frame: On day 8 of each sleep condition (2 time points)
Assessed by the Matsuda index during a 2-hour oral glucose tolerance test (OGTT)
4 secondary outcomes
Insulin sensitivity
Time frame: On day 8 of each sleep condition (2 time points)
Blood lipids
Time frame: On day 8 of each sleep condition (2 time points)
Food intake
Time frame: On days 5, 6 and 7 of each sleep condition (2 time points)
Physical activity level
Time frame: During each 7-day sleep condition (2 time points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 42192565Dutil C, Podinic I, Walsh JJ, Goldfield GS, Chaput JP. Effect of Sleep Duration Manipulation on Brain-Derived Neurotrophic Factor in Adolescents at Risk for Type 2 Diabetes: A Randomized Crossover Study. J Sleep Res. 2026 May 26:e70375. doi: 10.1111/jsr.70375. Online ahead of print.
- Derived from this study: PubMed 38070132Dutil C, Podinic I, Featherstone RB, Eaton A, Sadler CM, Goldfield GS, Hadjiyannakis S, Gruber R, Tremblay MS, Prud'homme D, Chaput JP. Sleep and insulin sensitivity in adolescents at risk of type 2 diabetes: the Sleep Manipulation in Adolescents at Risk of Type 2 Diabetes randomized crossover study. Sleep. 2024 May 10;47(5):zsad313. doi: 10.1093/sleep/zsad313.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 manipulation in people with Sleep, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jul 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity (time frame: On day 8 of each sleep condition (2 time points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754036, which also lists 2 linked publications.
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 19 Jul 2022.