The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
NCT ID: NCT05994586
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-05-25
2023-11-26
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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AP029 mix - type II diabetes
Patients with type II diabetes receiving metformin for up to 5 months
AP029 mix
Polyphenol-rich plant extracts Twice a day
AP029 mix - prediabetes
Patients with pre-diabetic
AP029 mix
Polyphenol-rich plant extracts Twice a day
Placebo - type II diabetes
Patients with type II diabetes receiving metformin for up to 5 months
Placebo
Twice a day
Placebo - prediabetes
Patients with pre-diabetic
Placebo
Twice a day
Interventions
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AP029 mix
Polyphenol-rich plant extracts Twice a day
Placebo
Twice a day
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with type II diabetes mellitus
* Patients on metformin treatment up to 5 months
* BMI 20-35 kg/m2
* Signed informed consent
* 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
* 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)
* 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)
18 Years
75 Years
ALL
No
Sponsors
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AronPharma Sp. z o. o.
INDUSTRY
Responsible Party
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Locations
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Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, , Poland
Countries
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Facility Contacts
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Other Identifiers
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07-AP-MET
Identifier Type: -
Identifier Source: org_study_id
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