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The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

PreDiabetes Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05994586
Study type Interventional
Source AronPharma Sp. z o. o.
Contact
Status Recruiting
Phase N/A
Start date May 25, 2023
Completion date November 26, 2023
View Details
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