NCT03355092

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

November 22, 2017

Last Update Submit

April 25, 2019

Conditions

Type2 DiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • Mean reduction in HbA1c

    at 12 months after baseline

Study Arms (2)

vBloc Therapy + Usual Care for Type 2 Diabetes

EXPERIMENTAL
Device: vBloc Therapy

Usual Care for Type 2 Diabetes

NO INTERVENTION

Interventions

vBloc TherapyDEVICE

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.

vBloc Therapy + Usual Care for Type 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with HbA1c level 7-10% inclusive, AND known duration of disease ≤10 years, AND
  • Male or female (females of child-birth potential not pregnant at implant or for duration of study), AND
  • Age 18 years or older, AND
  • Body mass index (BMI) 35-45 kg/m2 inclusive, AND
  • Attempt and failed diet, exercise and behavioral modification program within past five years,

You may not qualify if:

  • Use of GLP-1 receptor agonists for diabetes currently or within past 6 months
  • Contraindications to vBloc (permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators))
  • 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)
  • 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
  • Previous bariatric or upper GI surgery
  • Excessive alcohol intake
  • Current smokers or smoking cessation in prior 3 months
  • An underlying disease known to have important effects on glucose metabolism
  • Active infections
  • Anemia (Hemoglobin \<11g/dl in women, \<12 g/dl in men) or known coagulopathy
  • Chronic kidney disease manifest as serum creatinine \>2.0 mg/dl
  • Diabetic retinopathy requiring photocoagulation therapy
  • Symptomatic diabetic gastroparesis
  • Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure
  • Cirrhosis of the liver, portal hypertension, or esophageal varices
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente South Bay Medical Center

Harbor City, California, 90710, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anny Xiang, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 28, 2017

Study Start

February 23, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

US(1)