Clinical trial NCT03568409: ABO-GLYC in Type 2 Diabetes
Official title: Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Latis S.r.l.
name: Fondazione Edmund Mach
First posted: 2018-06-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Week0 and Week24
measure: 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.
timeFrame: Week0 and Week24
measure: 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.
timeFrame: Week0 and Week24
Secondary outcomes:
measure: Improvement of markers of glycemic variability (plasma glucose level)
timeFrame: Week0 to Week24
measure: Improvement of markers of glycemic variability (MAGE)
timeFrame: Week0 to Week24
measure: Improvement of markers of glycemic variability (HBGl)
timeFrame: Week0 to Week24
measure: Improvement of markers of glycemic variability (LBGI)
timeFrame: Week0 to Week24
measure: Improvement of markers of glycemic variability (hypo/hyper glycemia)
timeFrame: Week0 to Week24
measure: Improvement of markers of metabolic status (BMI)
timeFrame: Week0 to Week24
measure: Improvement of markers of glyco-oxidative stress
timeFrame: Week0 to Week24
measure: Improvement of markers of inflammation
timeFrame: Week0 to Week24
measure: Improvement of markers of metabolic status (lipid profile)
timeFrame: Week0 to Week24
measure: Improvement of markers of metabolic status (body composition)
timeFrame: Week0 to Week24
measure: Evaluation of gut microbiome changes (bacteria population)
timeFrame: Week 0, Week 1, Week 12, Week 24
measure: Evaluation of gut microbiome changes (SCFA)
timeFrame: Week 0, Week 1, Week 12, Week 24
measure: Improvement in markers of insulin resistance
timeFrame: Week 0 and Week 24
measure: Improvement in markers of insulin secretion after standardized meal.
timeFrame: Week 0 and Week 24
measure: Evaluation of the dietary adherence
timeFrame: Week0 to Week24
measure: Adverse events (AEs) evaluation and product tolerability.
timeFrame: Week0 to Week24
measure: Control of the glycemia.
timeFrame: Week0 to Week24
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera Padova
Study officials:
References: