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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
30
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, Poland
RECRUITINGGlucose level
Comparison of glucose level
Time frame: Baseline, 2 months, 3 months, 5 months
Insulin level
Comparison of insulin level
Time frame: Baseline, 2 months, 3 months, 5 months
Discomfort related to metformin side effects
Based on questionnaire
Time frame: Baseline, 2 months, 3 months, 5 months
Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
Comparison of lipid panel markers
Time frame: Baseline, 2 months, 3 months, 5 months
hsCRP level
Comparison of hsCRP level
Time frame: Baseline, 2 months, 3 months, 5 months
HbA1c level
Comparison of hbA1c level
Time frame: Baseline, 2 months, 3 months, 5 months
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