Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546085
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Extracellular Vesicles Insulin Action and Exercise
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extracellular Vesicles Insulin Action and Exercise on Vascular Function in Type 2 Diabetes
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:
Extracellular vesicles EVs play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease However little is known on how EVs affect vascular insulin action in people The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease This research will also study if exercise can change how EVs impact blood flow and metabolic health This study will contribute to designing precision medicine to treatprevent cardiovascular disease in type 2 diabetes
Detailed Description:
Insulin resistance is a key underlying factor promoting hyperglycemia and hypertension in people with type 2 diabetes T2D who have a 3-fold greater cardiovascular disease CVD risk when compared with healthy controls Despite several therapeutic approaches that favor insulin sensitivity through a variety of purported mechanisms eg weight loss incretins AMPK activation reduction in bioactive lipids DAGceramides etc long-term progression of glucose deterioration occurs This suggests adjunctive targets may be important to preventreverse T2D Studies show that extracellular vesicles EVs obtained from plasma are involved in obesity-induced insulin resistance at levels of adipocytes muscle and liver However little is known how plasma EVs affect vascular insulin action in humans This is of clinical relevance as EVs enhance the Framingham Risk Score suggesting EVs are a unique factor promoting CVD This proposal will fill this knowledge gap by conducting a translational study in 3 distinct groups of people separated by obesity and T2D The investigators hypothesize that 1 insulin will promote EV uptake and modify insulin signaling in endothelial cells 2 EVs from adults with T2D will impair vessel reactivity compared to controls 3 insulin will alter circulating EV insulin signaling and cargo and 4 exercise training will change EV uptake and cargo as well as EV mediated vascular reactivity to insulin as well as relate to improved vascular function in humans
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