PreDiabetesNCT06507722
Night Owl Metabolism
A study testing Timing of OGTT and Timing of Standardized Meal in people with PreDiabetes and Overweight, run by Johns Hopkins University at 1 site in United States.
Trial summary
The proposed study uses a novel and rigorous randomized cross-over study design in youth (18-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Overweight, Impaired Glucose Tolerance
- What is being tested?
- Timing of OGTT and Timing of Standardized Meal
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Jan 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 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight similar to (BMI ≥ 85th percentile but <95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and <95th percentile equivalents for a 20-year-old will be used))
- Post-pubertal
- Normal sleep duration (avg. >7 hours of sleep per night)
- Social jetlag (difference between weekend and weekday sleep) of < 2 hours.
Who cannot join
- Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome
- Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm
- Screening high risk for obstructive sleep apnea
- Night shift work.
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
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Talia Hitt, MD/MPH/MSHP, 860-324-0072, thitt2@jhmi.edu
About this study
Official title: Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth
The proposed study uses a novel and rigorous randomized cross-over study design in youth (18-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.
- Conditions
- PreDiabetes, Overweight, Impaired Glucose Tolerance
- Being tested
- Timing of OGTT, Timing of Standardized Meal
- Keywords
- chronotype, sleep
- Medical subject headings
- Prediabetic State, Overweight, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of OGTTDiagnostic test
In Aim 1, timing of oral glucose tolerance test will be altered.
Timing of Standardized MealBehavioural
In Aim 2, timing of a standardized meal will be altered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Late Chronotype first, then alternate | Other | Sleep onset after 2am Receives: Diagnostic Test: Timing of OGTT; Behavioral: Timing of Standardized Meal |
| Cohort B - Non-late Chronotype first, then alternate | Other | Sleep onset before 11pm Receives: Diagnostic Test: Timing of OGTT; Behavioral: Timing of Standardized Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Hour Difference in Glucose
Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
Insulin Sensitivity (by Oral Minimal Model)
Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
2-hour Incremental Area Under the Curve (iAUC) for glucose
Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.
Measured: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Secondary outcomes (13)
Difference in Fasting Glucose
Within-subject difference in fasting glucose at start of OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 obtained before OGTT
Insulin secretion indices
Within-subject difference in insulin secretion (dynamic phase, static phase, total and insulin secretory rate) from c-peptide minimal model between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
Incremental Area Under the Curve (iAUC) for Insulin
Within-subject difference in iAUC for insulin after glucose ingestion between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
Hemoglobin A1c levels
Analysis of between group differences in hemoglobin A1c levels
Measured: Day 4 of Aim 1 during first OGTT Visit
Difference in Disposition Index
Within-subject difference in disposition index (derived from insulin sensitivity and insulin secretion metrics) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
Difference in Insulin Clearance
Within-subject difference in insulin clearance (derived from Watanabe et al. model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Measured: Day 4 and Day 11 of Aim 1 derived from OGTT
Mean Glucose
Analysis of between group differences in mean glucose derived from continuous glucose monitor
Measured: Up to 8 days
Percent Time Spent Above 120 mg/dL
Analysis of between group differences in time spent above 120 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days)]
Measured: Up to 8 days
Percent Time Spent Above 140 mg/dL
Analysis of between group differences in time spent above 140 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).
Measured: Up to 8 days
Number of Excursions greater than 140mg/dL
Analysis of between group differences in the number of excursions above 140 mg/dL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).
Measured: Up to 8 days
Difference in Post-prandial peak
Within-subject difference in post-prandial peak from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal
Measured: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Standard Deviation of Glucose
Analysis of between group differences in standard deviation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).
Measured: Up to 8 days
Coefficient of Variation of Glucose
Analysis of between group differences in coefficient of variation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start25 Feb 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Model description
- For randomization in Aim 1, participants will be assigned to Early or Late OGTT for the first visit with crossover to the alternate for the second visit. In Aim 2, participants will be assigned to Early or Late standardized first meal with crossover at least one week later.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Lawson Wilkins Pediatric Endocrine Society, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Talia Hitt, MD/MPH/MSHP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507722
- Sponsor's protocol ID
- IRB00428863
- Status last verified
- May 2026
- First submitted
- 12 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth
- ClinicalTrials.gov ID
- NCT06507722
- Acronym / sponsor ID
- IRB00428863
- Conditions
- PreDiabetes, Overweight, Impaired Glucose Tolerance
- Keywords
- chronotype, sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Lawson Wilkins Pediatric Endocrine Society, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 18 Jul 2024 (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.
The proposed study uses a novel and rigorous randomized cross-over study design in youth (18-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For randomization in Aim 1, participants will be assigned to Early or Late OGTT for the first visit with crossover to the alternate for the second visit. In Aim 2, participants will be assigned to Early or Late standardized first meal with crossover at least one week later.
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Late Chronotype first, then alternate | Other | Diagnostic Test: Timing of OGTT, Behavioral: Timing of Standardized MealSleep onset after 2am |
| Cohort B - Non-late Chronotype first, then alternate | Other | Diagnostic Test: Timing of OGTT, Behavioral: Timing of Standardized MealSleep onset before 11pm |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Overweight similar to (BMI ≥ 85th percentile but <95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and <95th percentile equivalents for a 20-year-old will be used))
- Post-pubertal
- Normal sleep duration (avg. >7 hours of sleep per night)
- Social jetlag (difference between weekend and weekday sleep) of < 2 hours.
Key exclusion criteria (4 listed)
- Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome
- Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm
- Screening high risk for obstructive sleep apnea
- Night shift work.
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 |
|---|---|---|
| Timing of OGTTIn Aim 1, timing of oral glucose tolerance test will be altered. | Diagnostic test | Cohort A - Late Chronotype first, then alternate, Cohort B - Non-late Chronotype first, then alternate |
| Timing of Standardized MealIn Aim 2, timing of a standardized meal will be altered. | Behavioural | Cohort A - Late Chronotype first, then alternate, Cohort B - Non-late Chronotype first, then alternate |
Primary outcome
2-Hour Difference in Glucose
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
Insulin Sensitivity (by Oral Minimal Model)
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.
2-hour Incremental Area Under the Curve (iAUC) for glucose
Time frame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.
13 secondary outcomes
Difference in Fasting Glucose
Time frame: Day 4 and Day 11 of Aim 1 obtained before OGTT
Insulin secretion indices
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Incremental Area Under the Curve (iAUC) for Insulin
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Hemoglobin A1c levels
Time frame: Day 4 of Aim 1 during first OGTT Visit
Difference in Disposition Index
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Difference in Insulin Clearance
Time frame: Day 4 and Day 11 of Aim 1 derived from OGTT
Mean Glucose
Time frame: Up to 8 days
Percent Time Spent Above 120 mg/dL
Time frame: Up to 8 days
Percent Time Spent Above 140 mg/dL
Time frame: Up to 8 days
Number of Excursions greater than 140mg/dL
Time frame: Up to 8 days
Difference in Post-prandial peak
Time frame: Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal
Standard Deviation of Glucose
Time frame: Up to 8 days
Coefficient of Variation of Glucose
Time frame: Up to 8 days
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 11 May 2026.
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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.
Talia Hitt, MD/MPH/MSHP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of OGTT and Timing of Standardized Meal in people with PreDiabetes and Overweight, run by Johns Hopkins University 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 4 inclusion and 4 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 11 May 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 Talia Hitt, MD/MPH/MSHP (860-324-0072, thitt2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Hour Difference in Glucose (time frame: Day 4 and Day 11 of Aim 1 derived from OGTT). The study lists 3 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 11 May 2026.