ABO-GLYC in Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568409
• Other study ID #: ABO-GLYC-16
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Aboca Spa Societa' Agricola
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• ABO-GLYC
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

Other:
• ABO-GLYC Placebo
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Padova	Padova

Sponsors (3)

Lead Sponsor	Collaborator
Aboca Spa Societa' Agricola	Fondazione Edmund Mach, Latis S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Improvement of markers of glycemic variability (MAGE)	mean amplitude of glucose excursion (MAGE)	Week0 to Week24
Secondary	Improvement of markers of glycemic variability (HBGl)	high blood glycemic index (HBGI)	Week0 to Week24
Secondary	Improvement of markers of glycemic variability (LBGI)	, low blood glycemic index (LBGI)	Week0 to Week24
Secondary	Improvement of markers of glycemic variability (hypo/hyper glycemia)	percentage of time spent in hypoglycemia or hyperglycemia	Week0 to Week24
Secondary	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
Secondary	Improvement of markers of glyco-oxidative stress	Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL	Week0 to Week24
Secondary	Improvement of markers of inflammation	Measurement of TNF-alpha, IL-1, IL-6	Week0 to Week24
Secondary	Improvement of markers of metabolic status (lipid profile)	Measurement of total cholesterol, HDL cholesterol and Tryglycerides	Week0 to Week24
Secondary	Improvement of markers of metabolic status (body composition)	percentage of body fat determined by bioimpedentiometry	Week0 to Week24
Secondary	Evaluation of gut microbiome changes (bacteria population)	Evaluation of bacteria population	Week 0, Week 1, Week 12, Week 24
Secondary	Evaluation of gut microbiome changes (SCFA)	Evaluation of short change fatty acids measurements (SCFA)	Week 0, Week 1, Week 12, Week 24
Secondary	Improvement in markers of insulin resistance	Measurement of HOMA-IR and QUICKI	Week 0 and Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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