The vBlocT2D Study
|ClinicalTrials.gov Identifier: NCT03355092|
Recruitment Status : Withdrawn (Funding)
First Posted : November 28, 2017
Last Update Posted : April 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes Obesity||Device: vBloc Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||vBloc Therapy for Obese Subjects With Type 2 Diabetes- A Randomized Controlled Clinical Trial|
|Actual Study Start Date :||February 23, 2018|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
|Experimental: vBloc Therapy + Usual Care for Type 2 Diabetes||
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.
|No Intervention: Usual Care for Type 2 Diabetes|
- Mean reduction in HbA1c [ Time Frame: at 12 months after baseline ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355092
|United States, California|
|Kaiser Permanente South Bay Medical Center|
|Harbor City, California, United States, 90710|
|Principal Investigator:||Anny Xiang, PhD||Kaiser Permanente|