Cryovagotomy Diabetes Trial
Condition: Diabetes Type 2; Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Detailed description: 
      Obesity is a growing epidemic, currently affecting over 1/3 of the adult US population and is
      a well-established risk factor for the development of diabetes and cardiovascular disease.
      Given that the majority of patients with type 2 diabetes (T2D) are obese, weight loss is the
      cornerstone of treatment, and has been shown to decrease risk of long term complications,
      lead to improvements in A1c and lipid levels, as well as decreased need for medications and
      improvements in quality of life. Unfortunately, lifestyle intervention is often ineffective
      at achieving long-term sustainable, clinically significant weight loss. Bariatric surgery is
      a successful intervention, leading to 20-30% weight loss with remission of diabetes in 30-65%
      of patients 1-5 years post surgery. However, this invasive procedure is associated with high
      rates of short- and long-term complications, including need for reoperations, vitamin/mineral
      deficiencies, anemia, and osteoporosis. It is clear that the current management options for
      obese patients, including lifestyle changes, medications and surgery, are suboptimal and
      innovative strategies are necessary to optimize diabetes control and weight management.

      Energy balance and glycemic control are mediated largely by the gut-brain axis, specifically
      the vagus nerve. The vagus nerve can stimulate or inhibit food intake depending on
      nutritional status. Vagal nerve signaling is disrupted in the setting of obesity and thought
      to contribute to overeating behaviors. Vagus nerve blockade has the potential to be a highly
      efficacious, minimally invasive intervention to address current obesity treatment
      limitations. Clinical studies evaluating the efficacy of an implantable electric vagus nerve
      blockade device found that subjects lost on average 8.8% of total body weight at 1 year;
      patients with T2D experienced improved glycemic control, with an average A1c improvement of
      1.0% at 12 months. Unfortunately, nearly 40% of subjects experienced side effects related to
      the device. A recent pilot study from the researchers of this study reported weight loss
      efficacy of a minimally invasive computerized tomography (CT) guided cryoablation of the
      vagus nerve in obese, non-diabetic subjects. Patients lost 5.6% of total body weight and
      22.7% excess body weight at 6 months with no significant side effects. The purpose of this
      current study is to evaluate the feasibility and efficacy of this procedure through a
      randomized control trial in obese patients with T2D. The researchers hypothesize that those
      patients undergoing the cryoablation procedure will experience improvement in glycemic
      control and enhanced weight loss at 6 months follow-up compared to the control group.

      Participants will be randomized to receive either CT guided cryoablation of the vagus nerve
      plus lifestyle intervention or lifestyle intervention alone. The lifestyle intervention lasts
      for 26 weeks and participants will be followed for 12 months in total.
    

Intervention name(s): Cryoablation of the Vagus Nerve; Lifestyle Intervention
Intervention type(s): Device; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Visual ICE Cryoablation System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Diabetes; Neurophysiology; Cryovagotomy; Glycemic control