Cryovagotomy Diabetes Trial

Summary

The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.

Conditions

• Diabetes Type 2
• Diabetes Mellitus
• Obesity

Interventions

DEVICE

Cryoablation of the Vagus Nerve

The Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology. The procedure will be done under CT guidance and involves a 4-5 mm scalpel incision followed by percutaneous probe placement about the posterior gastroesophageal junction (the location of the posterior vagal trunk). The probe will create a zone of decreased temperature (-20 to -40 degrees Celsius) involving the posterior vagal nerve fibers/plexus. The cryoablation process will include a 3-minute freeze, followed by a 1-minute thaw, and a second 3-minute freeze and 1 minute thaw.

BEHAVIORAL

Lifestyle Intervention

The lifestyle intervention structure will include three face-to-face counseling sessions at baseline, 3 and 6 months. Dietary counseling to follow a low carbohydrate diet will be provided by a registered dietitian. Focus will be on increasing fruits and vegetables and decreasing refined sugars and processed foods. It will also include motivational interviewing, goal setting and nutrition education. In addition, subjects will be encouraged by exercise physiologist to slowly increase physical activity to at least 150 minutes weekly. There will be weekly phone calls or texts (participants' choice) providing a total of 26 points of contact recommended by the United States Preventive Services Task Force.

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Alexandra Migdal, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-23

Primary Completion

2022-02-08

Completion

2022-02-08

FDA Device

Yes

Countries

• United States

Study Locations