The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Not Applicable

Recruiting

• Conditions: PreDiabetes; Diabetes in Adolescence
• Interventions: Other: Placebo; Dietary Supplement: AP029 mix

• Registration Number: NCT05994586
• Lead Sponsor: AronPharma Sp. z o. o.

Brief 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

Study Timeline

• Study Start: 2023-05-25
• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Primary Completion: 2023-11-26
• Study Completion: 2023-11-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo - prediabetes	Placebo	Patients with pre-diabetic
AP029 mix - type II diabetes	AP029 mix	Patients with type II diabetes receiving metformin for up to 5 months
AP029 mix - prediabetes	AP029 mix	Patients with pre-diabetic
Placebo - type II diabetes	Placebo	Patients with type II diabetes receiving metformin for up to 5 months

Primary Outcome Measures

Name	Time	Method
Glucose level	Baseline, 2 months, 3 months, 5 months	Comparison of glucose level
Discomfort related to metformin side effects	Baseline, 2 months, 3 months, 5 months	Based on questionnaire
Insulin level	Baseline, 2 months, 3 months, 5 months	Comparison of insulin level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko; 🇵🇱 Sopot, Poland