NCT03355092

The vBlocT2D Study

vBloc Therapy for Obese Subjects With Type 2 Diabetes- A Randomized Controlled Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Overall aim: To demonstrate that weight loss through vBloc Therapy in combination with usual care will achieve better glycemic control for patients with obesity and type 2 diabetes than usual care alone. Duration: Participants will be asked to participate in a 12 month study that involves a baseline visit and research follow-up visits at 3, 6, 9, and 12 months. Sample Size: 60 participants will be enrolled in the study. Of these, 30 will be randomized to vBloc therapy and 30 will be randomized to usual care.

Detailed description

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.

Conditions

• Type2 Diabetes
• Obesity

Interventions

Type	Name	Description
DEVICE	vBloc Therapy	The vBloc device will be placed using a laparoscopic procedure. The participants will be followed according to standard clinical practice and vBloc therapy protocol under the supervision of study surgeons. . Pre-operative testing will be conducted per surgeon's evaluation. Participants will receive weight management education according to the vBloc Therapy protocol.

Timeline

• Start date: 2018-02-23
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-11-28
• Last updated: 2019-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study