Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-22 @ 10:28 AM
Study NCT ID:
NCT06526494
Status:
WITHDRAWN
Last Update Posted:
2025-12-24
First Post:
2024-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Vascular Function in Prediabetes
Sponsor:
Diana Jalal
Organization:
Study Overview
Official Title:
Metformin and Vascular Function in Prediabetes
Status:
WITHDRAWN
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding
Has Expanded Access:
False
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 metformin's 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 metformin's potential to reduce CVD risk and prevent the progression to diabetes in individuals with prediabetes.
Study Oversight
Has Oversight DMC:
True
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?: