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CompletedNCT03568409Updated Jun 30, 2022

ABO-GLYC in Type 2 Diabetes

An interventional study of ABO-GLYC and ABO-GLYC Placebo in Type2 Diabetes, sponsored by Aboca Spa Societa' Agricola. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Aboca Spa Societa' Agricola · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type2 Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 86 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Aboca Spa Societa' Agricola is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Group A: ABO-GLYC

    Libramed

    Device: ABO-GLYC

  • Placebo comparator
    Group B: Placebo

    Other: ABO-GLYC Placebo

Interventions

  • DeviceABO-GLYC

    3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

    Also known as: Libramed

  • OtherABO-GLYC Placebo

    3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week0 and Week24

  2. 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

    Time frame: Week0 and Week24

  3. 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

    Time frame: Week0 and Week24

Secondary outcomes

  1. Improvement of markers of glycemic variability (plasma glucose level)

    Composite measurement of standard deviation and coefficient of variation of the plasma glucose level

    Time frame: Week0 to Week24

  2. Improvement of markers of glycemic variability (MAGE)

    mean amplitude of glucose excursion (MAGE)

    Time frame: Week0 to Week24

  3. Improvement of markers of glycemic variability (HBGl)

    high blood glycemic index (HBGI)

    Time frame: Week0 to Week24

  4. Improvement of markers of glycemic variability (LBGI)

    , low blood glycemic index (LBGI)

    Time frame: Week0 to Week24

  5. Improvement of markers of glycemic variability (hypo/hyper glycemia)

    percentage of time spent in hypoglycemia or hyperglycemia

    Time frame: Week0 to Week24

  6. 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

    Time frame: Week0 to Week24

  7. Improvement of markers of glyco-oxidative stress

    Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL

    Time frame: Week0 to Week24

  8. Improvement of markers of inflammation

    Measurement of TNF-alpha, IL-1, IL-6

    Time frame: Week0 to Week24

  9. Improvement of markers of metabolic status (lipid profile)

    Measurement of total cholesterol, HDL cholesterol and Tryglycerides

    Time frame: Week0 to Week24

  10. Improvement of markers of metabolic status (body composition)

    percentage of body fat determined by bioimpedentiometry

    Time frame: Week0 to Week24

  11. Evaluation of gut microbiome changes (bacteria population)

    Evaluation of bacteria population

    Time frame: Week 0, Week 1, Week 12, Week 24

  12. Evaluation of gut microbiome changes (SCFA)

    Evaluation of short change fatty acids measurements (SCFA)

    Time frame: Week 0, Week 1, Week 12, Week 24

  13. Improvement in markers of insulin resistance

    Measurement of HOMA-IR and QUICKI

    Time frame: Week 0 and Week 24

  14. 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

    Time frame: Week 0 and Week 24

  15. Evaluation of the dietary adherence

    Perceived Dietary Adherence Questionnaire (PDAQ). The PDAQ uses a 5-point Likert scale to assess perceived difficulty.

    Time frame: Week0 to Week24

  16. 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

    Time frame: Week0 to Week24

  17. 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).

    Time frame: Week0 to Week24

07

Study locations

1 site
  • Azienda Ospedaliera Padova
    Padova, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03568409
Lead sponsor
Aboca Spa Societa' Agricola
Collaborators
Latis S.r.l., Fondazione Edmund Mach
Responsible party
Sponsor
First posted
Jun 26, 2018
Start date
Jun 1, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jun 30, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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