The vBlocT2D Study

The vBlocT2D study is a two arm, randomized, controlled, unblinded clinical trial in which 60
adult patients with T2D with moderate to extreme obesity (BMI 35-45 kg/m2) and suboptimal
glycemic control (glycated haemoglobin (HbA1c) 7-10%) without significant diabetic
complications, will be randomized to usual care alone (n=30) or vBloc therapy plus usual care
(n=30) to assess the superiority of vBloc therapy plus usual care than standard usual care
alone in improving diabetic control. The vBloc therapy will be delivered through an
electrical and reversible vagal blocking device (the Maestro Rechargeable System) implanted
using laparoscopic surgery. The device was approved by the FDA in 2015 for weight loss in
adults with BMI 40-45 kg/m2, or BMI 35-39.9 kg/m2 with one or more obesity-related co-morbid
conditions. The study will recruit patients over a 12-month period and follow each individual
for 12-months post intervention. The primary outcome is change in HbA1c at 12-months post
randomization. The secondary outcomes are changes in weight, waist and hip circumferences,
blood pressure, lipids, insulin sensitivity and β-cell health measured through oral glucose
tolerance testing, dietary intake, eating behaviors, physical activity, quality of life and
potential circulating biomarkers. Medication use, clinical labs and adverse events will be
compared as well.

Inclusion Criteria:

1. Type 2 diabetes with HbA1c level 7-10% inclusive, AND known duration of disease ≤10
years, AND

2. Male or female (females of child-birth potential not pregnant at implant or for
duration of study), AND

3. Age 18 years or older, AND

4. Body mass index (BMI) 35-45 kg/m2 inclusive, AND

5. Attempt and failed diet, exercise and behavioral modification program within past five
years,

Exclusion Criteria:

1. Use of GLP-1 receptor agonists for diabetes currently or within past 6 months

2. Contraindications to vBloc (permanently implanted, electrical-powered medical device
or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators,
neurostimulators))

3. Patients for whom magnetic resonance imaging (MRI), shortwave, microwave, or
therapeutic ultrasound diathermy is planned (Note: Diathermy is any treatment that
uses high-frequency electromagnetic radiation, electric currents, or ultrasonic waves
to produce heat in body tissues. Patients absolutely CANNOT be treated with any type
of shortwave, microwave, or therapeutic ultrasound diathermy device whether or not it
is used to produce heat. These treatments should not be applied anywhere on the body)

4. Underlying disease(s) likely to (a) limit life span to less than study duration and/or
(b) increase risk of intervention outside of the study and/or (c) limit ability to
participate in outcomes assessment and/or (d) limit participation

5. Previous bariatric or upper GI surgery

6. Excessive alcohol intake

7. Current smokers or smoking cessation in prior 3 months

8. An underlying disease known to have important effects on glucose metabolism

9. Active infections

10. Anemia (Hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy

11. Chronic kidney disease manifest as serum creatinine >2.0 mg/dl

12. Diabetic retinopathy requiring photocoagulation therapy

13. Symptomatic diabetic gastroparesis

14. Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive
heart failure

15. Cirrhosis of the liver, portal hypertension, or esophageal varices

16. Symptomatic esophageal reflux

17. Conditions or behaviors likely to affect the conduct of the vBloc Study

1. Unable or unwilling to give informed consent

2. Unable to adequately communicate with clinic staff

3. Current or anticipated participation in another intervention research project
that would interfere with any of the interventions/outcomes in vBloc study

4. Likely to move away from participating clinic in next 2 years

5. Current (or anticipated) pregnancy and lactation.

6. Major psychiatric disorder that, in the opinion of investigators, would impede
participation in the study

7. Weight loss >7% in past two months for any reason except postpartum weight loss.

18. Additional conditions may serve as criteria for exclusion at the discretion of the
study investigators.