The vBlocT2D Study

Withdrawn before enrolling · Not applicable

Conditions studied: Type2 Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT03355092

Run by

Kaiser Permanente

People needed

0

Starts

2018-02-23

Expected to finish

2018-11-30

Last updated by the study team

2019-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Symptomatic esophageal reflux
• Conditions or behaviors likely to affect the conduct of the vBloc Study
• Unable or unwilling to give informed consent
• Unable to adequately communicate with clinic staff
• Current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in vBloc study
• Likely to move away from participating clinic in next 2 years
• Current (or anticipated) pregnancy and lactation.
• Major psychiatric disorder that, in the opinion of investigators, would impede participation in the study
• Weight loss >7% in past two months for any reason except postpartum weight loss.
• Additional conditions may serve as criteria for exclusion at the discretion of the study investigators.

Where it is running

• Kaiser Permanente South Bay Medical Center — Harbor City, California, United States

Full record on ClinicalTrials.gov

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