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| Name | Class |
|---|---|
| Latis S.r.l. | INDUSTRY |
| Fondazione Edmund Mach | OTHER |
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Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: ABO-GLYC | Experimental | Libramed |
|
| Group B: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABO-GLYC | Device | 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak. | HbA1c measure | Week0 and Week24 |
| Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak. | Tmax | Week0 and Week24 |
| Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak. | Cmax | Week0 and Week24 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of markers of glycemic variability (plasma glucose level) | Composite measurement of standard deviation and coefficient of variation of the plasma glucose level | Week0 to Week24 |
| Improvement of markers of glycemic variability (MAGE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Padova | Padova | Italy |
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| ABO-GLYC Placebo | Other | 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks. |
|
mean amplitude of glucose excursion (MAGE)
| Week0 to Week24 |
| Improvement of markers of glycemic variability (HBGl) | high blood glycemic index (HBGI) | Week0 to Week24 |
| Improvement of markers of glycemic variability (LBGI) | , low blood glycemic index (LBGI) | Week0 to Week24 |
| Improvement of markers of glycemic variability (hypo/hyper glycemia) | percentage of time spent in hypoglycemia or hyperglycemia | Week0 to Week24 |
| Improvement of markers of metabolic status (BMI) | Weight and height will be combined to report BMI in kg/m^2,total cholesterol, LDL triglycerides or NEFA, HDL and in the percentage of body fat determined by bioimpedentiometry | Week0 to Week24 |
| Improvement of markers of glyco-oxidative stress | Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL | Week0 to Week24 |
| Improvement of markers of inflammation | Measurement of TNF-alpha, IL-1, IL-6 | Week0 to Week24 |
| Improvement of markers of metabolic status (lipid profile) | Measurement of total cholesterol, HDL cholesterol and Tryglycerides | Week0 to Week24 |
| Improvement of markers of metabolic status (body composition) | percentage of body fat determined by bioimpedentiometry | Week0 to Week24 |
| Evaluation of gut microbiome changes (bacteria population) | Evaluation of bacteria population | Week 0, Week 1, Week 12, Week 24 |
| Evaluation of gut microbiome changes (SCFA) | Evaluation of short change fatty acids measurements (SCFA) | Week 0, Week 1, Week 12, Week 24 |
| Improvement in markers of insulin resistance | Measurement of HOMA-IR and QUICKI | Week 0 and Week 24 |
| Improvement in markers of insulin secretion after standardized meal. | Measurement of insulin and c-peptide secretion measured during the glycemic curve after a standardized meal | Week 0 and Week 24 |
| Evaluation of the dietary adherence | Perceived Dietary Adherence Questionnaire (PDAQ). The PDAQ uses a 5-point Likert scale to assess perceived difficulty. | Week0 to Week24 |
| Adverse events (AEs) evaluation and product tolerability. | Adverse event will be recorded during the course of the study, after the signature of the informed consent | Week0 to Week24 |
| Control of the glycemia. | The data from the glycemic diary will be monitored to assess the good control of the glycemia as measured by Self Monitoring of Blood Glucose (SMBG). | Week0 to Week24 |