NCT05994586

The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AronPharma Sp. z o. o. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Diabetes in Adolescence
• PreDiabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AP029 mix	Polyphenol-rich plant extracts Twice a day
OTHER	Placebo	Twice a day

Timeline

• Start date: 2023-05-25
• Primary completion: 2023-11-26
• Completion: 2023-11-26
• First posted: 2023-08-16
• Last updated: 2023-08-16

Locations

1 site across 1 country: Poland