The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Sponsor

AronPharma Sp. z o. o. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05994586

Collaborator

(none)

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes in Adolescence PreDiabetes	Dietary Supplement: AP029 mix Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

Nov 26, 2023

Anticipated Study Completion Date :

Nov 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AP029 mix - type II diabetes Patients with type II diabetes receiving metformin for up to 5 months	Dietary Supplement: AP029 mix Polyphenol-rich plant extracts Twice a day
Experimental: AP029 mix - prediabetes Patients with pre-diabetic	Dietary Supplement: AP029 mix Polyphenol-rich plant extracts Twice a day
Placebo Comparator: Placebo - type II diabetes Patients with type II diabetes receiving metformin for up to 5 months	Other: Placebo Twice a day
Placebo Comparator: Placebo - prediabetes Patients with pre-diabetic	Other: Placebo Twice a day

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)