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ABO-GLYC in Type 2 Diabetes

Sponsor
Aboca Spa Societa' Agricola (Industry)
Overall Status
Completed
CT.gov ID
NCT03568409
Collaborator
Latis S.r.l. (Industry), Fondazione Edmund Mach (Other)
86
Enrollment
1
Location
2
Arms
55
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ABO-GLYC
  • Other: ABO-GLYC Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes
Actual Study Start Date :
Jun 1, 2017
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    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. [Week0 and Week24]

      HbA1c measure

    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. [Week0 and Week24]

      Tmax

    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. [Week0 and Week24]

      Cmax

    Secondary Outcome Measures

    1. 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

    2. Improvement of markers of glycemic variability (MAGE) [Week0 to Week24]

      mean amplitude of glucose excursion (MAGE)

    3. Improvement of markers of glycemic variability (HBGl) [Week0 to Week24]

      high blood glycemic index (HBGI)

    4. Improvement of markers of glycemic variability (LBGI) [Week0 to Week24]

      , low blood glycemic index (LBGI)

    5. Improvement of markers of glycemic variability (hypo/hyper glycemia) [Week0 to Week24]

      percentage of time spent in hypoglycemia or hyperglycemia

    6. 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

    7. Improvement of markers of glyco-oxidative stress [Week0 to Week24]

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

    8. Improvement of markers of inflammation [Week0 to Week24]

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

    9. Improvement of markers of metabolic status (lipid profile) [Week0 to Week24]

      Measurement of total cholesterol, HDL cholesterol and Tryglycerides

    10. Improvement of markers of metabolic status (body composition) [Week0 to Week24]

      percentage of body fat determined by bioimpedentiometry

    11. Evaluation of gut microbiome changes (bacteria population) [Week 0, Week 1, Week 12, Week 24]

      Evaluation of bacteria population

    12. Evaluation of gut microbiome changes (SCFA) [Week 0, Week 1, Week 12, Week 24]

      Evaluation of short change fatty acids measurements (SCFA)

    13. Improvement in markers of insulin resistance [Week 0 and Week 24]

      Measurement of HOMA-IR and QUICKI

    14. 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

    15. 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.

    16. 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

    17. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    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:

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera Padova Padova Italy

    Sponsors and Collaborators

    • Aboca Spa Societa' Agricola
    • Latis S.r.l.
    • Fondazione Edmund Mach

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aboca Spa Societa' Agricola
    ClinicalTrials.gov Identifier:
    NCT03568409
    Other Study ID Numbers:
    • ABO-GLYC-16
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jun 30, 2022