ABO-GLYC in Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Device: ABO-GLYC; Other: ABO-GLYC Placebo

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy
    • Azienda Ospedaliera Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: ABO-GLYC; Libramed	Device: ABO-GLYC; 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.; Other Names: Libramed
Placebo Comparator: Group B: Placebo	Other: ABO-GLYC Placebo; 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Aboca Spa Societa' Agricola
• Collaborators: Latis S.r.l.; Fondazione Edmund Mach

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ABO-GLYC-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No