The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

AronPharma

Status: Enrolling

Conditions: Diabetes in Adolescence; PreDiabetes

Treatments: Dietary Supplement: AP029 mix; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05994586

07-AP-MET

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

AP029 mix - type II diabetes

Experimental group

Description:

Patients with type II diabetes receiving metformin for up to 5 months

Treatment:

Dietary Supplement: AP029 mix

AP029 mix - prediabetes

Experimental group

Description:

Patients with pre-diabetic

Treatment:

Dietary Supplement: AP029 mix

Placebo - type II diabetes

Placebo Comparator group

Description:

Patients with type II diabetes receiving metformin for up to 5 months

Treatment:

Other: Placebo

Placebo - prediabetes

Placebo Comparator group

Description:

Patients with pre-diabetic

Treatment:

Other: Placebo