The DIAMOND for the Treatment of Type 2 Diabetes: Can Blood Triglycerides level be the predictor for therapy efficiency?

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objectives of this study are 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. The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Secondary Objective: Not Applicable;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for:<br>1.Low blood TG patients<br>2.High blood TG patients<br>3. High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy<br>;Timepoint(s) of evaluation of this end point: Baseline vs 12 month post implant

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Trends in weight loss will be of a reduction in weight during treatment in 3 patient groups <br>2. Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups<br>;Timepoint(s) of evaluation of this end point: Baseline vs 12 month post implant