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The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.
The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.
The study protocol will also apply measures to better understand the mechanism of action of the effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical signal ON | Experimental | Subjects randomized to this group (Group A) will receive electrical stimulation delivered to the fundus for 24 months. |
|
| Sham | Sham Comparator | Subjects randomized to this group (Group B) will have their device in "turned off" mode for the first 12 months (48 weeks) after implant. Then the device will be turned ON and these subjects will receive therapy for the remaining 12 months of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIAMOND System | Device | Electrical stimulation to the fundus |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The primary end point will be the difference, at 12 months, in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The difference, at 6 months in HbA1c change from baseline, between the pts treated with the active signal compared to patients treated with a Sham System. | 6 months |
| GI hormones (C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan W.M. Greve, MD | Atrium medisch centrum METC, Heerlen, The Netherlands | Principal Investigator |
| Chevallier, MD | Hôpital GEORGES POMPIDOU 20 Rue Leblanc 75015 Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Georges Pompidou | Paris | France | ||||
| Atrium Medisch Centrum |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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To detect differences in the pattern of meal-related release of GI hormones (slope / area under the curve, etc)between the treatment and the control groups, as analyzed by repeated-measures ANOVA. Glucose, insulin and the following GI hormones will be measured prior and post meal consumption: C-peptide, Glucagon, Ghrelin, GLP-1, PYY, Gastrin and Somatostatin. |
| 6 and 12 months |
| Metabolic parameters (fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference) | The difference in metabolic parameters at 6 and 12 months from baseline between the two arms. Including: fasting and post Prandial glucose, blood pressure, lipids and cholesterol, weight and waist circumference. | 6 and 12 months |
| Triglycerides | The effect of the TG level at baseline on treatment efficacy | Baseline |
| HbA1c | The change in HbA1c from baseline to 12 months and 24 months | 24 months |
| Heerlen |
| Netherlands |
| D004700 | Endocrine System Diseases |