Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507722
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Night Owl Metabolism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Night Owl Metabolism Investigating the Impact of Chronotype on Glucose Metabolism in Youth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study uses a novel and rigorous randomized cross-over study design in youth 17-23y with late and non-late chronotype n35 per group to assess the glycemic effect of aligning an oral glucose tolerance test OGTT or first-meal of day to a subjects 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 n12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None