DIAMOND device to evaluate the blood Triglycerides level level in patients with type 2 diabetes.

Phase 1

• Conditions: diabetes type 2; MedDRA version: 21.0Level: LLTClassification code 10012659Term: Diabetic control impairedSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-001003-36-IT
• Lead Sponsor: METACURE LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-06-17
• Study Start: 2021-01-21
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Subjects 18 through 70 years of age, overweight and obese, Type 2 diabetes, with a body mass index (BMI) of 30 to 45 (kg/m2) and poor glycemic control defined as HbA1c = 7.3% and = 9.5% and fasting blood glucose (FBG) between 120-350 mg/dL.
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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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; any condition(s) for which it is contraindicated the possible intake of fenofibrate.

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<br>efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c and the relationship between blood TG level and the GCM efficacy.;Secondary Objective: The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.;Primary end point(s): Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for:<br>- Low blood TG patients;<br>- High blood TG patients;<br>- High blood TG patients treated with blood TG<br>lowering therapy concomitant with GCM therapy.;Timepoint(s) of evaluation of this end point: 13 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Trends in weight loss will be of a reduction in weight<br>during treatment in 3 patient groups; Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups; Trends in improvement in metabolic parameters such as waist circumference, blood pressure and lipids 3 patient<br>groups.;Timepoint(s) of evaluation of this end point: 13 months