The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Last updated: August 9, 2023
Sponsor: AronPharma Sp. z o. o.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Diabetes Prevention

Diabetes And Hypertension

Treatment

AP029 mix

Placebo

Clinical Study ID

NCT05994586
07-AP-MET
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: AP029 mix
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
November 26, 2023

Study 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

Connect with a study center

  • Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

    Sopot, 81-820
    Poland

    Active - Recruiting

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