Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470295
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-01
First Post:
2024-06-17
Brief Title:
Effect of C-peptide on Hypoglycemic Counterregulation
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
On the Regulation of Hepatic Glucose Metabolism During Insulin-induced Hypoglycemia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
Iatrogenic hypoglycemia is the most prominent barrier to the safe effective management of blood sugar in people with type 1 diabetes due to periodic over-insulinization During insulin-induced hypoglycemia glucagon secretion is diminished in type 1 diabetes which in turn reduces hepatic glucose production and increases the depth and duration of hypoglycemic episodes We have observed that the naturally occurring protein C-peptide increases glucagon secretion in dogs during insulin-induced hypoglycemia which increases hepatic glucose production the experiments in this application will shed light on the translation of this finding to the human
Detailed Description:
Iatrogenic hypoglycemia is recognized as a primary barrier to the safe effective management of blood glucose in people with type 1 diabetes T1D In previous experiments in the dog we observed that C-peptide infusion augmented glucagon secretion and hepatic glucose production during insulin-induced hypoglycemia The proposed experiments will determine the translational impact of this finding in patients with and without T1D
Specific Aim 1 is to determine in healthy control subjects the effect of C-peptide co-infusion with insulin on endogenous glucose production EGP and counterregulatory hormone levels during hypoglycemia This will be addressed by studying a single group of healthy subjects two times In both studies hypoglycemia will be induced with an intravenous IV infusion of insulin During one study C-peptide will be infused during the hypoglycemic period and in the other study saline will be infused EGP is our primary variable with secondary analyses including counterregulatory hormones and metabolic substrates
Specific Aim 2 is to determine in T1D patients the effect of C-peptide co-infusion with insulin on EGP and counterregulatory hormone levels during hypoglycemia The research plan for this Aim is very similar to that of Aim 1 with the main exception being that we will study T1D patients instead of healthy controls eg two hypoglycemic clamp studies where C-peptide is administered during one study and saline during the other In addition the glycemic levels of these T1D patients will be monitored for 10 days prior to this visit to ensure that they do not experience hypoglycemia which could confound the data for the metabolic studies Similar to Aim 1 EGP is our primary outcome variable with secondary analyses including hormone and substrate levels
Specific Aim 1 is to determine in healthy control subjects the effect of C-peptide co-infusion with insulin on endogenous glucose production EGP and counterregulatory hormone levels during hypoglycemia This will be addressed by studying a single group of healthy subjects two times In both studies hypoglycemia will be induced with an intravenous IV infusion of insulin During one study C-peptide will be infused during the hypoglycemic period and in the other study saline will be infused EGP is our primary variable with secondary analyses including counterregulatory hormones and metabolic substrates
Specific Aim 2 is to determine in T1D patients the effect of C-peptide co-infusion with insulin on EGP and counterregulatory hormone levels during hypoglycemia The research plan for this Aim is very similar to that of Aim 1 with the main exception being that we will study T1D patients instead of healthy controls eg two hypoglycemic clamp studies where C-peptide is administered during one study and saline during the other In addition the glycemic levels of these T1D patients will be monitored for 10 days prior to this visit to ensure that they do not experience hypoglycemia which could confound the data for the metabolic studies Similar to Aim 1 EGP is our primary outcome variable with secondary analyses including hormone and substrate levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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