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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05994586
• Other study ID #: 07-AP-MET
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: November 26, 2023

Study information

• Verified date: August 2023
• Source: AronPharma Sp. z o. o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 26, 2023
• Est. primary completion date: November 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• AP029 mix
Polyphenol-rich plant extracts Twice a day

Other:
• Placebo
Twice a day

Locations

Country	Name	City	State
Poland	Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko	Sopot

Sponsors (1)

Lead Sponsor	Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose level	Comparison of glucose level	Baseline, 2 months, 3 months, 5 months
Primary	Insulin level	Comparison of insulin level	Baseline, 2 months, 3 months, 5 months
Primary	Discomfort related to metformin side effects	Based on questionnaire	Baseline, 2 months, 3 months, 5 months
Secondary	Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)	Comparison of lipid panel markers	Baseline, 2 months, 3 months, 5 months
Secondary	hsCRP level	Comparison of hsCRP level	Baseline, 2 months, 3 months, 5 months
Secondary	HbA1c level	Comparison of hbA1c level	Baseline, 2 months, 3 months, 5 months