Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606327
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Diazoxide Suppression Test PF Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Human Models of Primary Hyperinsulinemia Diazoxide Suppression Test DzST Pilot Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
DzST
Brief Summary:
The goal of this study is to learn about how the hormone insulin controls blood sugar The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level People with obesity and high insulin levels will receive eight doses of diazoxide a drug that suppresses the pancreass production of insulin and will have their fasting blood sugar and insulin levels checked daily while taking the drug
Detailed Description:
The investigators are interested in determining 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 study 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 the study team has developed a modification of the insulin suppression test IST called the graded IST GIST that suppresses endogenous insulin secretion with octreotide and then measures steady-state plasma glucose SSPG at both replacement euinsulinemia and hyperinsulinemia It is expected that some people with high insulin levels at baseline will not demonstrate a prominent rise in SSPG even when their insulin levels are lowered However the GIST is a cumbersome procedure that is difficult to scale for larger study populations As such the investigators are also working to develop an outpatient diazoxide suppression test DzST that suppresses endogenous insulin secretion with the oral insulin anti-secretagogue diazoxide rather than octreotide and will validate it against the incipient gold-standard GIST GIST participants found to have evidence of primary hyperinsulinemia ie euinsulinemic euglycemia or near-euglycemia despite baseline hyperinsulinemia will several weeks later take diazoxide 3 mgkg per dose twice daily for four days The investigators will check fasting glucose and insulin levels daily at baseline and then after each of the four days of diazoxide administration The investigators expect that suppression of insulin secretion with diazoxide will in accordance with the GIST lead to no significant rise in blood glucose in people who have true primary hyperinsulinemia
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