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The DIAMOND® for the Treatment of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02079376
Recruitment Status : Unknown
Verified March 2016 by Metacure.
Recruitment status was:  Recruiting
First Posted : March 5, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Metacure

Brief Summary:

Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c.

Relationship between blood TG level and the GCM efficacy will be evaluated.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: DIAMOND System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The DIAMOND® for the Treatment of Type 2 Diabetes: Can Blood Triglycerides Level be the Predictor for Therapy Efficiency A Multicentre, Prospective, Semi-randomized Study
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low blood TG patients
subjects with baseline blood triglyceride level ≤ 1.7 mmol/l will have intervention device (DIAMOND Implantable Pulse Generator (IPG)) programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period.
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)

Experimental: High blood TG patients treated with blood TG lowering therapy
subjects with baseline blood triglyceride level > 1.7 mmol/l will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period and will receive fenofibrate at the dose of 160mg per day
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)

Placebo Comparator: High blood TG patients
subjects with baseline blood triglyceride level > 1.7 mmol/l will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for a 48 weeks period and will receive placebo of fenofibrate administered in the same schedule as the drug.
Device: DIAMOND System
DIAMOND Implantable Pulse Generator (IPG)




Primary Outcome Measures :
  1. improvement of HbA1c [ Time Frame: 48 weeks ]
    improvement of glycemic control measured by changes in HbA1c


Secondary Outcome Measures :
  1. Relationship between blood TG level and the GCM efficacy [ Time Frame: 48 weeks ]
    Relationship between blood TG level and the GCM efficacy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 through 70 years of age
  • Body mass index > 30 and < 45 (kg/m2)
  • Type 2 diabetes duration of at least 6 months
  • Type 2 diabetic subjects treated with oral anti-diabetic agents [Sulfonylurea, Metformin, thiazolinedione (TZD) or DPP-4 inhibitors]
  • Stable anti-diabetic medications for at least 3 months prior to enrollment, six months for thiazolinedione (TZD)
  • The subject has been under routine diabetes care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
  • HbA1c 7.3% and ≤ 9.5 % on Visit 1
  • Stable HbA1c, defined as no significant change (variation ≤ 0.5%) between a historical value recorded in the subject's medical record within 3 months prior to enrollment and the HbA1c gathered on Visit 1.
  • Fasting blood glucose >120 and < 350 mg/dl on Visit 1.
  • Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  • Stable weight, defined as no significant weight change (variation <3%) within three months prior to enrollment as documented in the subject's medical record. For the subject treated with thiazolinedione, stable weight within six months.
  • If taking theses medication, sable anti-hypertensive and lipid-lowering medication for at least one month prior to enrollment
  • If subject is under anti-depressant medication the treatment needs to be stable for at least six months prior to enrollment.
  • Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the DIAMOND System
  • Willingness to perform at least four (3) capillary blood glucose tests per day twice a week for the duration of the study
  • Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
  • Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
  • Able to provide voluntary informed consent

Exclusion Criteria:

  • Insulin therapy in last 3 months
  • Taking GLP-1 agonists or in the last 3 months before the enrollment
  • Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment
  • Subjects with an EF less than 35% or otherwise indicated for an ICD
  • Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
  • Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
  • Prior wound healing problems due to staphylococcus or candida
  • Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
  • Use of anti-psychotic medications
  • Diagnosed with a eating disorder such as bulimia or binge eating
  • Obesity due to an endocrine disorder (e.g. Cushing disease)
  • Pregnant or lactating
  • Diagnosed with impaired liver function (liver enzymes 3 times greater than normal)
  • Any prior bariatric surgery
  • Any history of pancreatitis
  • Any history of peptic ulcer disease within 5 years of enrollment
  • Diagnosed with gastroparesis
  • Use of active medical devices (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
  • Cardiac history that physician feels should exclude the subject from the study.
  • Use of another investigator device or agent in the 30 days prior to enrollment
  • A history of life-threatening disease within 5 years of enrollment
  • Change in diabetic medication from between Visit 1 and Visit 3.
  • Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

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): NCT02079376


Locations
Australia
Epworth Research Institute Recruiting
Richmond, Victoria, Australia
Contact: Spiros Fourlanos, MD       spiros.fourlanos@nh.org.au   
Austria
Tilak Innsbruck Withdrawn
Innsbruck, Austria
Greece
"Attikon" Hospital Active, not recruiting
AThens, Greece
"Evgenidio " Hospital Recruiting
Athens, Greece
Contact: Nikolaos Arkadopoulos, Prof.    306937106217      
Italy
Clinica Pineta Grande Recruiting
Rome, Italy
Contact: Dott. Cristiano Giardiello, MD    +39335406848      
The Università Cattolica del Sacro Cuore Recruiting
Rome, Italy
Contact: Gertrude Mingrone, Prof.       paolo.ferrazza@lnage.it   
Poland
Medical University Recruiting
Bialystok, Poland
Contact: Maria Górska, MD, PhD    48857468239      
Medical University Recruiting
Bydgoszcz, Poland
Contact: Roman Junik, MD, PhD    48525854020      
"Diabeta-Care" Recruiting
Lubin, Poland
Contact: Irena Szykowna, MD, PhD    48693729109      
Medical University Recruiting
Szczecin, Poland
Contact: Syrenicz Anhelli, MD, PhD    4860170884      
Centre for Postgraduate Medical Education (CMKP) Recruiting
Warsaw, Poland
Contact: Wiesław Tarnowski, MD, PhD    +48602346242      
Serbia
Klinika za digestivnu hirurgiju Recruiting
Belgrade, Serbia
Contact: Miloš BJELOVIĆ, Prof. dr       acerimanovic@hungarotrial.com   
Principal Investigator: Miloš BJELOVIĆ, Prof. dr         
Institut za pluće bolesti Vojvodine Recruiting
Kamenica, Serbia
Contact: Miroslav ILIĆ, Prof. dr       acerimanovic@hungarotrial.com   
Principal Investigator: Miroslav ILIĆ, Prof. dr         
Sponsors and Collaborators
Metacure

Responsible Party: Metacure
ClinicalTrials.gov Identifier: NCT02079376     History of Changes
Other Study ID Numbers: MC CP TAN2012-60
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Metacure:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases