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The vBlocT2D Study

NCT03355092 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-04-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Anny Xiang, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-23
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355092 on ClinicalTrials.gov