Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143267
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-09
Brief Title:
Neuronostatin - a Glucagonotropic Agent in Humans
Sponsor:
University Hospital Gentofte Copenhagen
Organization:
University Hospital Gentofte Copenhagen
Study Overview
Official Title:
Neuronostatin - a Glucagonotropic Agent in Humans
Status:
RECRUITING
Status Verified Date:
2023-11
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:
NSTCLAMP
Brief Summary:
With the present study the investigators wish to delineate the effects of neuronostatin-13 NST on glucose-dependent glucagon secretion in humans The main question it aims to answer is
What are the physiological effects of the naturally occuring hormone NST - especially with regards to glucagonotropic effects at different plasma glucose concentrations
In a randomized double-blind crossover design participants will undergo six experimental days with controlled plasma glucose levels consisting of two euglycemic two hyperglycemic around 8mmoll and two hypoglycemic around 25mmoll days with each pair of similar days involving the administration of either saline placebo or NST
What are the physiological effects of the naturally occuring hormone NST - especially with regards to glucagonotropic effects at different plasma glucose concentrations
In a randomized double-blind crossover design participants will undergo six experimental days with controlled plasma glucose levels consisting of two euglycemic two hyperglycemic around 8mmoll and two hypoglycemic around 25mmoll days with each pair of similar days involving the administration of either saline placebo or NST
Detailed Description:
With the present study the investigators wish to delineate the effects of neuronostatin on glucose-dependent glucagon secretion in humans Thus this study is designed to elucidate the physiological effects of the natural occurring hormone neuronostatin and not to examine a medical effect of a drug or treatment However if neuronostatin acts glucagonotropically during low plasma glucose concentrations it could potentially help to address the unmet medical need for a treatment that ultimately can counteract the high risk of hypoglycaemia in patients treated with insulin
After being informed about the study and the potential risks each participant giving written informed consent will participate in six double-blinded experimental days Day A-F in a randomized order On each day participants will receive an infusion of either saline placeboday A C and E or NST day B D and F On day A and B blood glucose will be kept at fasting levels on day C and D blood glucose will be increased to 8mmoll and on day E and F blood glucose will be lowered to 25mmoll
Blood glucose will be adjusted with insulin andor glucose to reach the desired levels on each day
At the end of the study day participants will receive an ad libitum meal
The effects of each infusion will be evaluated with regards to glucagonotropic potency as well as a series of exploratory outcomes
After being informed about the study and the potential risks each participant giving written informed consent will participate in six double-blinded experimental days Day A-F in a randomized order On each day participants will receive an infusion of either saline placeboday A C and E or NST day B D and F On day A and B blood glucose will be kept at fasting levels on day C and D blood glucose will be increased to 8mmoll and on day E and F blood glucose will be lowered to 25mmoll
Blood glucose will be adjusted with insulin andor glucose to reach the desired levels on each day
At the end of the study day participants will receive an ad libitum meal
The effects of each infusion will be evaluated with regards to glucagonotropic potency as well as a series of exploratory outcomes
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