Clinical trial NCT05994586: The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes in Adolescence
PreDiabetes
Keywords: Type II diabetes
Prediabetes
Disorders of Carbohydrate Metabolism
Chokeberry
Elderberry
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.

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 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

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)

Primary outcomes:
measure: Glucose level
timeFrame: Baseline, 2 months, 3 months, 5 months
measure: Insulin level
timeFrame: Baseline, 2 months, 3 months, 5 months
measure: Discomfort related to metformin side effects
timeFrame: Baseline, 2 months, 3 months, 5 months
Secondary outcomes:
measure: Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
timeFrame: Baseline, 2 months, 3 months, 5 months
measure: hsCRP level
timeFrame: Baseline, 2 months, 3 months, 5 months
measure: HbA1c level
timeFrame: Baseline, 2 months, 3 months, 5 months
Other outcomes:
Locations:
city: Sopot
country: Poland
facility: Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Study officials:
References: