Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569721
Status:
WITHDRAWN
Last Update Posted:
2021-07-28
First Post:
2020-09-25
Brief Title:
Percutaneous CT-guided Cryoablation of the Splanchnic Nerves
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Percutaneous CT-guided Cryoablation of the Splanchnic Nerves for the Management of Type 2 Diabetes
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There was only one subject consented and it was a screen failure No participants enrolled and study is being closed due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of freezing cryoablation of the splanchnic nerve for management of diabetes The splanchnic nerves carry signals from the brain to help regulate the way organs function Quieting these signals by freezing the splanchnic nerves may help the body regulate blood sugar The study procedure will take about 30 minutes and the researchers hope that it will help people to control their blood sugars lose weight and possibly improve blood pressure
Detailed Description:
Type 2 diabetes T2D is a disease of pandemic proportion affecting approximately 425 million adults worldwide The incidence of T2D is increasing in most countries and it is predicted that by the year 2045 629 million adults will be diagnosed with T2D worldwide Chronically elevated sympathetic activity has been shown to contribute to the development of metabolic syndrome and T2D Overweightobese individuals demonstrate elevated noradrenaline and metabolite levels relative to lean healthy individuals - this is particularly concerning since long term prospective studies have shown that noradrenaline levels predict future risk of T2D Furthermore dysfunctional sympathetic response to glucose loads is demonstrated amongst those with T2D compared to pre-diabetes Since the greater splanchnic nerve is the main source of sympathetic input to the viscera the researchers postulate that denervation of the splanchnic nerve would lead to decreased sympathetic tone thereby improving glycemic control in patients with T2D To the researchers knowledge this would be the first study to evaluate the role of splanchnic cryoablation as a potential therapeutic for T2D and insulin resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None