The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Study Overview
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Brief Summary
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The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.

Detailed Description
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Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 20 patients with type II diabetes and 2) group of 10 patients with prediabetes. Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed: level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In addition, a questionnaire of symptoms associated with metformin intake will be conducted

Official Title
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The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism

Conditions
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Diabetes in Adolescence, PreDiabetes

Intervention / Treatment
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* Dietary Supplement: AP029 mix
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for type II diabetes: Women and men, 18-75 years old Patients diagnosed with type II diabetes mellitus Patients on metformin treatment up to 5 months BMI 20-35 kg/m2 Signed informed consent Inclusion Criteria for prediabetes: Women and men, 18-75 years old BMI 20-35 kg/m2 Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l) Signed informed consent Exclusion Criteria for type II diabetes: Patients diagnosed with type I diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl) Exclusion Criteria for prediabetes: Patients diagnosed with type I, II, LADA diabetes Patients receiving insulin or other anti-diabetic medications Women who are pregnant, planning to become pregnant during the study, or breastfeeding Surgery within the last 6 months Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins Intake of supplements containing: white mulberry, chromium, berberine Patients receiving glucocorticosteroids, immunosuppressants Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant Acute inflammation (C-reactive protein >20mg/dl)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP029 mix - type II diabetes<br>Patients with type II diabetes receiving metformin for up to 5 months | Dietary Supplement: AP029 mix<br>* Polyphenol-rich plant extracts Twice a day<br>|
| Experimental: AP029 mix - prediabetes<br>Patients with pre-diabetic | Dietary Supplement: AP029 mix<br>* Polyphenol-rich plant extracts Twice a day<br>|
| Placebo Comparator: Placebo - type II diabetes<br>Patients with type II diabetes receiving metformin for up to 5 months | Other: Placebo<br>* Twice a day<br>|
| Placebo Comparator: Placebo - prediabetes<br>Patients with pre-diabetic | Other: Placebo<br>* Twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose level | Comparison of glucose level | Baseline, 2 months, 3 months, 5 months | 
| Insulin level | Comparison of insulin level | Baseline, 2 months, 3 months, 5 months | 
| Discomfort related to metformin side effects | Based on questionnaire | Baseline, 2 months, 3 months, 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL) | Comparison of lipid panel markers | Baseline, 2 months, 3 months, 5 months | 
| hsCRP level | Comparison of hsCRP level | Baseline, 2 months, 3 months, 5 months | 
| HbA1c level | Comparison of hbA1c level | Baseline, 2 months, 3 months, 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry