Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295640
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-02-08
Brief Title:
Relative Contribution of Brain Insulin Action for Postprandial Metabolism
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Relative Contribution of Brain Insulin Action for Postprandial Metabolism
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrainInsPPM
Brief Summary:
The goal of this clinical trial is to clarify i the contribution of brain insulin action on regulation of systemic metabolism ii sex-specific differences in the central regulation and iii the influence of the menstrual cycle in women
Therefore participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray
Therefore participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray
Detailed Description:
This research project aims to investigate to what extent brain insulin action is responsible for the control of postprandial metabolism compared to direct effects of insulin in peripheral target tissues Furthermore the study will investigate sex differences and the influence of the menstrual cycle on brain-derived coordination of postprandial signaling for metabolic control
Therefore insulin action in the brain will be introduced by application of insulin as nasal spray on one day versus carrier solution as placebo nasal spray on another day in a randomized blinded fashion Spray administration will be performed 15 minutes before a 75 gram oral glucose tolerance test that will introduce a postprandial state On placebo day the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate iv insulin bolus This approach will be combined with a double-tracer dilution technique Labeled glucose 66-2Hglucose will be infused 120 minutes before and during the OGTT 180 min and will be used to address endogenous glucose production The glucose drink from the OGTT will be enriched with U-13C6glucose to compute the glucose appearance rate Ra Basal endogenous glucose production will be calculated as well as post-load endogenous glucose production and rates of glucose disappearances Rd Using this approach brain-derived regulation of postprandial metabolism including endogenous glucose production glucose disappearance insulin secretion and secretion of proglucagon-cleavage products incretins will be examined
Therefore insulin action in the brain will be introduced by application of insulin as nasal spray on one day versus carrier solution as placebo nasal spray on another day in a randomized blinded fashion Spray administration will be performed 15 minutes before a 75 gram oral glucose tolerance test that will introduce a postprandial state On placebo day the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate iv insulin bolus This approach will be combined with a double-tracer dilution technique Labeled glucose 66-2Hglucose will be infused 120 minutes before and during the OGTT 180 min and will be used to address endogenous glucose production The glucose drink from the OGTT will be enriched with U-13C6glucose to compute the glucose appearance rate Ra Basal endogenous glucose production will be calculated as well as post-load endogenous glucose production and rates of glucose disappearances Rd Using this approach brain-derived regulation of postprandial metabolism including endogenous glucose production glucose disappearance insulin secretion and secretion of proglucagon-cleavage products incretins will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None