Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558422
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Human Models of Selective Insulin Resistance Pancreatic Clamp
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Human Models of Selective Insulin Resistance Pancreatic Clamp
Status:
NOT_YET_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:
None
Brief Summary:
This is a single-center prospective randomized controlled crossover clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production HGP vs de novo lipogenesis DNL in people with insulin resistance The investigators will recruit participants with a history of overweightobesity and evidence of insulin resistance ie fasting hyperinsulinemia plus prediabetes andor impaired fasting glucose andor Homeostasis Model Assessment of Insulin Resistance HOMA-IR score 273 and with evidence of metabolic dysfunction-associated steatotic liver disease MASLD Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline Maintenance Hyperinsulinemia or MH Protocol and the other in which serum insulin levels are lowered by 50 Reduction toward Euinsulinemia or RE Protocol In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL
Detailed Description:
Although high blood sugar and risk of heart disease are the most well-known health effects of type 2 diabetes T2DM metabolic dysfunction-associated steatotic liver disease MASLD in which too much fat accumulates in the liver has come to be recognized as another important complication Unchecked MASLD can progress to severe liver inflammation liver failure and even liver cancer The investigators suspect that high levels of the blood sugar-lowering hormone insulin leads to excessive fat production by the liver and so lowering insulin levels might help to improve MASLD In order to answer this question the investigators will recruit people with MASLD at risk for T2DM to perform a pancreatic clamp - a procedure in which the bodys production of insulin is temporarily shut off and then replaced at the same or lower levels Again the investigators expect that lowering insulin levels will lower fat production de novo lipogenesis or DNL Research participants in this prospective randomized controlled crossover study will therefore undergo two pancreatic clamps in random order one roughly maintaining their own internal basal insulin level MH Protocol and one in which the investigators lower that basal insulin level by 50 RE Protocol In each case the investigators will observe the absolute and relative changes in the livers production of glucose hepatic glucose production HGP and of triglycerides de novo lipogenesis DNL using stable-isotope tracers
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