Type2 Diabetes
Conditions
Brief summary
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.
Interventions
DEVICEABO-GLYC
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
OTHERABO-GLYC Placebo
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
Sponsors
Latis S.r.l.
Fondazione Edmund Mach
Aboca Spa Societa' Agricola
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients with diagnosis of type 2 diabetes, aged 18-75 2. HbA1c at screening between 6.5% and 7.5% 3. Last 2 HbA1c values in the last 12 months between 6.5% and 7.5% 4. Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents 5. BMI 25-38 kg/m2 6. Willing and able to understand and sign the informed consent and complete the patient diary provided 7. Women participant of childbearing age should be negative to pregnancy test (performed on blood), and will have to use an appropriate contraceptive method throughout the study.
Exclusion criteria
1. Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI) 2. Chronic gastro-intestinal disease 3. Heavy smoker subjects 4. Alcohol abuse 5. Chronic liver and kidney disease (AST or ALT values \> 2.5 UNL or plasma creatinine \> 1.5 mg/dl) 6. Previous major gastrointestinal surgery 7. History of eating disorders 8. Pregnancy or lactation 9. Use of food supplements containing in particular but not limited to fibers and polysaccharides, in the last six months with frequency and dosage such as to interfere with the study. 10. Autoimmune diseases 11. Known hypersensitivity to any of the components of the product. 12. Any condition which prevent subject participation in the opinion of the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Week0 and Week24 | HbA1c measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of markers of glycemic variability (plasma glucose level) | Week0 to Week24 | Composite measurement of standard deviation and coefficient of variation of the plasma glucose level |
| Improvement of markers of glycemic variability (MAGE) | Week0 to Week24 | mean amplitude of glucose excursion (MAGE) |
| Improvement of markers of glycemic variability (HBGl) | Week0 to Week24 | high blood glycemic index (HBGI) |
| Improvement of markers of glycemic variability (LBGI) | Week0 to Week24 | , low blood glycemic index (LBGI) |
| Improvement of markers of glycemic variability (hypo/hyper glycemia) | Week0 to Week24 | percentage of time spent in hypoglycemia or hyperglycemia |
| Improvement of markers of metabolic status (BMI) | Week0 to Week24 | 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 |
| Improvement of markers of glyco-oxidative stress | Week0 to Week24 | Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL |
| Improvement of markers of inflammation | Week0 to Week24 | Measurement of TNF-alpha, IL-1, IL-6 |
| Adverse events (AEs) evaluation and product tolerability. | Week0 to Week24 | Adverse event will be recorded during the course of the study, after the signature of the informed consent |
| Improvement of markers of metabolic status (body composition) | Week0 to Week24 | percentage of body fat determined by bioimpedentiometry |
| Evaluation of gut microbiome changes (bacteria population) | Week 0, Week 1, Week 12, Week 24 | Evaluation of bacteria population |
| Evaluation of gut microbiome changes (SCFA) | Week 0, Week 1, Week 12, Week 24 | Evaluation of short change fatty acids measurements (SCFA) |
| Improvement in markers of insulin resistance | Week 0 and Week 24 | Measurement of HOMA-IR and QUICKI |
| Improvement in markers of insulin secretion after standardized meal. | Week 0 and Week 24 | Measurement of insulin and c-peptide secretion measured during the glycemic curve after a standardized meal |
| Evaluation of the dietary adherence | Week0 to Week24 | Perceived Dietary Adherence Questionnaire (PDAQ). The PDAQ uses a 5-point Likert scale to assess perceived difficulty. |
| Control of the glycemia. | Week0 to Week24 | 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). |
| Improvement of markers of metabolic status (lipid profile) | Week0 to Week24 | Measurement of total cholesterol, HDL cholesterol and Tryglycerides |
Countries
Italy
Outcome results
None listed