Evaluating the effects of AP029 Mix on carbohydrate metabolism in diabetes and prediabetes patients
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
This study is testing if a new supplement called AP029 Mix can help people with type II diabetes and prediabetes manage their blood sugar and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AronPharma Sp. z o. o. Industry-sponsored |
| Locations | 1 site (Sopot) |
| Trial ID | NCT05994586 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of AP029 Mix in patients with impaired carbohydrate metabolism, specifically those with type II diabetes and prediabetes. The study employs a randomized, double-blind, crossover design, where participants will receive AP029 supplementation for two months followed by a one-month wash-out period, and then a two-month placebo phase. Key health parameters, including glucose levels, insulin, HbA1c, and lipid profiles, will be monitored throughout the study to evaluate the impact of the intervention on metabolic health and side effects of metformin. The trial will involve a total of 30 participants, with regular medical supervision during the study period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with a diagnosis of type II diabetes on metformin or those with prediabetes and specific fasting blood glucose levels.
Not a fit: Patients with type I diabetes, those on insulin or other anti-diabetic medications, or individuals with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to enhance the effectiveness of metformin and improve metabolic health in patients with diabetes and prediabetes.
How similar studies have performed: While the specific combination of AP029 Mix has not been extensively tested, similar interventions targeting carbohydrate metabolism have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sopot
- Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko — Sopot, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.