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ABO-GLYC in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03568409
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : July 7, 2021
Sponsor:
Collaborators:
Latis S.r.l.
Fondazione Edmund Mach
Information provided by (Responsible Party):
Aboca Spa Societa' Agricola

Study Description
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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
Type2 Diabetes Device: ABO-GLYC Other: ABO-GLYC Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Week0 and Week24 ]
    Cmax


Secondary Outcome Measures :
  1. Improvement of markers of glycemic variability (plasma glucose level) [ Time Frame: 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) [ Time Frame: Week0 to Week24 ]
    mean amplitude of glucose excursion (MAGE)

  3. Improvement of markers of glycemic variability (HBGl) [ Time Frame: Week0 to Week24 ]
    high blood glycemic index (HBGI)

  4. Improvement of markers of glycemic variability (LBGI) [ Time Frame: Week0 to Week24 ]
    , low blood glycemic index (LBGI)

  5. Improvement of markers of glycemic variability (hypo/hyper glycemia) [ Time Frame: Week0 to Week24 ]
    percentage of time spent in hypoglycemia or hyperglycemia

  6. Improvement of markers of metabolic status (BMI) [ Time Frame: 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 [ Time Frame: Week0 to Week24 ]
    Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL

  8. Improvement of markers of inflammation [ Time Frame: Week0 to Week24 ]
    Measurement of TNF-alpha, IL-1, IL-6

  9. Improvement of markers of metabolic status (lipid profile) [ Time Frame: Week0 to Week24 ]
    Measurement of total cholesterol, HDL cholesterol and Tryglycerides

  10. Improvement of markers of metabolic status (body composition) [ Time Frame: Week0 to Week24 ]
    percentage of body fat determined by bioimpedentiometry

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

  12. Evaluation of gut microbiome changes (SCFA) [ Time Frame: Week 0, Week 1, Week 12, Week 24 ]
    Evaluation of short change fatty acids measurements (SCFA)

  13. Improvement in markers of insulin resistance [ Time Frame: Week 0 and Week 24 ]
    Measurement of HOMA-IR and QUICKI

  14. Improvement in markers of insulin secretion after standardized meal. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568409


Contacts
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Contact: Niccolò Ravenni, PhD +39 0575 746 ext 711 nravenni@aboca.it

Locations
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Italy
Azienda Ospedaliera Padova Recruiting
Padova, Italy
Contact: Roberto Vettor, Prof.         
Sub-Investigator: Nino Cristiano Chilelli, Dr.         
Sponsors and Collaborators
Aboca Spa Societa' Agricola
Latis S.r.l.
Fondazione Edmund Mach
More Information
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Responsible Party: Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier: NCT03568409    
Other Study ID Numbers: ABO-GLYC-16
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases