Status:
UNKNOWN
The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
Lead Sponsor:
AronPharma Sp. z o. o.
Conditions:
Diabetes in Adolescence
PreDiabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
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; I...
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...
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)
Exclusion
Key Trial Info
Start Date :
May 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 26 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05994586
Start Date
May 25 2023
End Date
November 26 2023
Last Update
August 16 2023
Active Locations (1)
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1
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, Poland, 81-820