Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526494
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Metformin and Vascular Function in Prediabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Metformin and Vascular Function in Prediabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to investigate whether metformin improves vascular function in individuals with prediabetes The main questions it aims to answer are
1 Does metformin improve large conduit artery endothelial function in individuals with prediabetes
2 Does metformin improve microvascular endothelial function in individuals with prediabetes
Researchers will compare metformin to a placebo to see if metformin improves vascular function in prediabetes
The trial duration is 12 weeks Participants will take metformin or a placebo once a day for 2 weeks After 2 weeks participants will take metformin or a placebo twice a day for the remaining 10 weeks There will be a screening visit two baseline visits a 4-week safety visit and two 12-week end-of-study visits Adherence will be calculated from pill count and adverse events will be quantified via a questionnaire
1 Does metformin improve large conduit artery endothelial function in individuals with prediabetes
2 Does metformin improve microvascular endothelial function in individuals with prediabetes
Researchers will compare metformin to a placebo to see if metformin improves vascular function in prediabetes
The trial duration is 12 weeks Participants will take metformin or a placebo once a day for 2 weeks After 2 weeks participants will take metformin or a placebo twice a day for the remaining 10 weeks There will be a screening visit two baseline visits a 4-week safety visit and two 12-week end-of-study visits Adherence will be calculated from pill count and adverse events will be quantified via a questionnaire
Detailed Description:
Prediabetes affects approximately 98 million people in the United States and significantly elevates the risk of cardiovascular disease CVD and progression to type-2 diabetes Endothelial dysfunction characterized by reduced nitric oxide bioavailability is a key subclinical risk factor contributing to the increased CVD risk in prediabetes Additionally endothelial dysfunction exacerbates insulin resistance and hyperglycemia further elevating the likelihood of progression to overt diabetes Thus targeting endothelial dysfunction in prediabetes presents a strategic opportunity to mitigate the risks of both CVD and overt diabetes
Hyperglycemia-induced reactive oxygen species ROS generation reduces nitric oxide bioavailability driving endothelial dysfunction in prediabetes Therefore interventions that lower hyperglycemia could decrease ROS production enhance nitric oxide bioavailability and improve endothelial function in prediabetes Metformin a first-line anti-diabetic agent lowers hyperglycemia by reducing hepatic glucose output and enhancing insulin-mediated glucose uptake Despite its established vascular benefits in diabetes the effects of metformin on endothelial function in prediabetes remain unexplored
This study will enroll 30 individuals in a randomized double-blind placebo-controlled clinical trial utilizing innovative methodologies to elucidate the vascular benefits of metformin in prediabetes Specifically the investigators will assess 1 large conduit artery endothelial function and 2 cutaneous microvascular endothelial function in prediabetes By investigating these mechanisms the investigators aim to provide critical insights into metformins potential to reduce CVD risk and prevent the progression to diabetes in individuals with prediabetes
Hyperglycemia-induced reactive oxygen species ROS generation reduces nitric oxide bioavailability driving endothelial dysfunction in prediabetes Therefore interventions that lower hyperglycemia could decrease ROS production enhance nitric oxide bioavailability and improve endothelial function in prediabetes Metformin a first-line anti-diabetic agent lowers hyperglycemia by reducing hepatic glucose output and enhancing insulin-mediated glucose uptake Despite its established vascular benefits in diabetes the effects of metformin on endothelial function in prediabetes remain unexplored
This study will enroll 30 individuals in a randomized double-blind placebo-controlled clinical trial utilizing innovative methodologies to elucidate the vascular benefits of metformin in prediabetes Specifically the investigators will assess 1 large conduit artery endothelial function and 2 cutaneous microvascular endothelial function in prediabetes By investigating these mechanisms the investigators aim to provide critical insights into metformins potential to reduce CVD risk and prevent the progression to diabetes in individuals with prediabetes
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