Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592261
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Graded Insulin Suppression Test PF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Human Models of Selective Insulin Resistance Graded Insulin Suppression Test GIST Pilot Feasibility Study
Status:
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:
GIST
Brief Summary:
The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level Participants will be asked to come in for a one-day study visit in which they will undergo a graded insulin suppression test GIST The GIST involves intravenous into the vein infusions of octreotide a medication that turns off the bodys own production of insulin as well as replacement insulin at two different levels low and high and glucose sugar The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes
Detailed Description:
This study aims to determine to what extent the hyperinsulinemia commonly associated with insulin resistance IR in those at risk for type 2 diabetes T2D is a primary phenomenon rather than merely a secondary compensatory response to IR The hypothesis is that some people with obesity and hyperinsulinemia exhibit a primary non-compensatory hyperinsulinemia that may foment IR and its dysmetabolic sequelae If this were the case lowering insulin levels should not result in a proportional rise in blood glucose as might be expected if the hyperinsulinemia truly were purely compensatory This hypothesis has been difficult to prove however because of the tight feedback mechanism between blood glucose and insulin secretion under normal circumstances insulin secretion declines only alongside blood glucose As such an attempt to lower insulin levels independently of blood glucose will raise blood glucose and trigger further insulin secretion negating the purpose of the experiment In order to circumvent this feedback regulation of glucose-stimulated insulin secretion this study will adapt the existing insulin suppression test IST technique which employs the somatostatin receptor ligand octreotide to suppress endogenous insulin secretion and then replaces insulin and dextrose exogenously as a measure of insulin action In addition to employing the current standard hyperinsulinemic IST protocol to assess insulin sensitivity this study will introduce a preceding euinsulinemic step in which insulin is lowered toward a healthy fasting serum insulin while assessing the resultant steady-state glucose The primary endpoints in this study are the steady-state plasma glucose and serum insulin levels during low- and high-dose insulin infusions meant to induce euinsulinemia and hyperinsulinemia respectively The study investigators will carefully monitor plasma glucose levels every 5-15 min drawing from an indwelling peripheral IV catheter and performing the analysis using a dedicated bedside glucose analyzer These glucose values will be used to detect and arrest any trends toward hypo or hyperglycemia and will also serve as the readout of the primary outcome - the euinsulinemic steady-state glucose E-SSG and hyperinsulinemic steady-state glucose H-SSG Serum insulin C-peptide growth hormone and glucagon levels will be measured periodically during the procedure but these results will not be available until several days later
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