The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

Launched by ARONPHARMA SP. Z O. O. · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a daily supplement called AP029 Mix to see if it can help people with diabetes or prediabetes. The researchers want to find out if this supplement can reduce some of the side effects caused by a common diabetes medication called metformin, while also improving its effectiveness. Additionally, they hope that AP029 Mix can help normalize certain blood sugar markers in people with prediabetes, which may prevent them from developing full diabetes in the future.

To participate in this trial, you need to be between 18 and 75 years old and have either type II diabetes (and currently taking metformin) or prediabetes (with specific blood sugar levels). Certain health conditions and medications might make you ineligible, so it’s important to review those carefully. If you decide to join, you can expect to take the supplement daily and have your health monitored throughout the study. This trial is currently recruiting participants, so it's a great opportunity for those looking to manage their diabetes or prediabetes more effectively.

Gender

ALL

Eligibility criteria

• 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)