- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03355092
The vBlocT2D Study
vBloc Therapy for Obese Subjects With Type 2 Diabetes- A Randomized Controlled Clinical Trial
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
California
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Harbor City, California, Stati Uniti, 90710
- Kaiser Permanente South Bay Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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,
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: vBloc Therapy + Usual Care for Type 2 Diabetes
|
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.
|
Nessun intervento: Usual Care for Type 2 Diabetes
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Mean reduction in HbA1c
Lasso di tempo: at 12 months after baseline
|
at 12 months after baseline
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Anny Xiang, PhD, Kaiser Permanente
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KPSC IRB 11343 (Altro identificatore: Kaiser Permanente Southern California IRB)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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