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The vBlocT2D Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355092
Recruitment Status : Withdrawn (Funding)
First Posted : November 28, 2017
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

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.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Obesity Device: vBloc Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean reduction in HbA1c [ Time Frame: at 12 months after baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355092


Locations
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United States, California
Kaiser Permanente South Bay Medical Center
Harbor City, California, United States, 90710
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Anny Xiang, PhD Kaiser Permanente
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03355092    
Other Study ID Numbers: KPSC IRB 11343
KPSC IRB 11343 ( Other Identifier: Kaiser Permanente Southern California IRB )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases