ABO-GLYC in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Device: ABO-GLYC; Other: ABO-GLYC Placebo

• Registration Number: NCT03568409
• Lead Sponsor: Aboca Spa Societa' Agricola

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Status Verified: 2021-07
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: ABO-GLYC	ABO-GLYC	Libramed
Group B: Placebo	ABO-GLYC Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improvement of markers of glycemic variability (HBGl)	Week0 to Week24	high blood glycemic index (HBGI)
Improvement of markers of glyco-oxidative stress	Week0 to Week24	Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL
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
Improvement of markers of glycemic variability (MAGE)	Week0 to Week24	mean amplitude of glucose excursion (MAGE)
Improvement of markers of glycemic variability (LBGI)	Week0 to Week24	, low blood glycemic index (LBGI)
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
Evaluation of gut microbiome changes (bacteria population)	Week 0, Week 1, Week 12, Week 24	Evaluation of bacteria population
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
Improvement of markers of glycemic variability (hypo/hyper glycemia)	Week0 to Week24	percentage of time spent in hypoglycemia or hyperglycemia
Improvement of markers of inflammation	Week0 to Week24	Measurement of TNF-alpha, IL-1, IL-6
Improvement of markers of metabolic status (lipid profile)	Week0 to Week24	Measurement of total cholesterol, HDL cholesterol and Tryglycerides
Improvement of markers of metabolic status (body composition)	Week0 to Week24	percentage of body fat determined by bioimpedentiometry
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).
Evaluation of gut microbiome changes (SCFA)	Week 0, Week 1, Week 12, Week 24	Evaluation of short change fatty acids measurements (SCFA)
Improvement in markers of insulin resistance	Week 0 and Week 24	Measurement of HOMA-IR and QUICKI
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.
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

Trial Locations

Locations (1)

Azienda Ospedaliera Padova; 🇮🇹 Padova, Italy