ABO-GLYC in Type 2 Diabetes

June 28, 2022 updated by: Aboca Spa Societa' Agricola

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy
        • Azienda Ospedaliera Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Week0 and Week24
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.
Time Frame: Week0 and Week24
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.
Time Frame: Week0 and Week24
Cmax
Week0 and Week24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Week0 to Week24
Improvement of markers of glycemic variability (MAGE)
Time Frame: Week0 to Week24
mean amplitude of glucose excursion (MAGE)
Week0 to Week24
Improvement of markers of glycemic variability (HBGl)
Time Frame: Week0 to Week24
high blood glycemic index (HBGI)
Week0 to Week24
Improvement of markers of glycemic variability (LBGI)
Time Frame: Week0 to Week24
, low blood glycemic index (LBGI)
Week0 to Week24
Improvement of markers of glycemic variability (hypo/hyper glycemia)
Time Frame: Week0 to Week24
percentage of time spent in hypoglycemia or hyperglycemia
Week0 to Week24
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
Week0 to Week24
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
Week0 to Week24
Improvement of markers of inflammation
Time Frame: Week0 to Week24
Measurement of TNF-alpha, IL-1, IL-6
Week0 to Week24
Improvement of markers of metabolic status (lipid profile)
Time Frame: Week0 to Week24
Measurement of total cholesterol, HDL cholesterol and Tryglycerides
Week0 to Week24
Improvement of markers of metabolic status (body composition)
Time Frame: Week0 to Week24
percentage of body fat determined by bioimpedentiometry
Week0 to Week24
Evaluation of gut microbiome changes (bacteria population)
Time Frame: Week 0, Week 1, Week 12, Week 24
Evaluation of bacteria population
Week 0, Week 1, Week 12, Week 24
Evaluation of gut microbiome changes (SCFA)
Time Frame: Week 0, Week 1, Week 12, Week 24
Evaluation of short change fatty acids measurements (SCFA)
Week 0, Week 1, Week 12, Week 24
Improvement in markers of insulin resistance
Time Frame: Week 0 and Week 24
Measurement of HOMA-IR and QUICKI
Week 0 and Week 24
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
Week 0 and Week 24
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.
Week0 to Week24
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
Week0 to Week24
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).
Week0 to Week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aboca Spa Societa' Agricola

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Latis S.r.l.
Fondazione Edmund Mach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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