Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility

Participation Requirements

Age
Between 22 years and 65 years
Gender
Both males and females

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 a...

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. Overweight/obese 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.

Tracking Information

NCT #
NCT04569721
Collaborators
Georgia Research Alliance
Investigators
Principal Investigator: John D Prologo, MD Emory University