The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
Diabetes in Adolescence, PreDiabetes
About this trial
This is an interventional supportive care trial for Diabetes in Adolescence focused on measuring Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry
Eligibility Criteria
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)
Sites / Locations
- Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-KoskoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
AP029 mix - type II diabetes
AP029 mix - prediabetes
Placebo - type II diabetes
Placebo - prediabetes
Patients with type II diabetes receiving metformin for up to 5 months
Patients with pre-diabetic
Patients with type II diabetes receiving metformin for up to 5 months
Patients with pre-diabetic