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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glucose level
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
AP029 mix - type II diabetes
Patients with type II diabetes receiving metformin for up to 5 months
干预措施: AP029 mix (Dietary Supplement)
AP029 mix - prediabetes
Patients with pre-diabetic
干预措施: AP029 mix (Dietary Supplement)
Placebo - type II diabetes
Patients with type II diabetes receiving metformin for up to 5 months
干预措施: Placebo (Other)
Placebo - prediabetes
Patients with pre-diabetic
干预措施: Placebo (Other)
结局指标
主要结局
Glucose level
时间窗: Baseline, 2 months, 3 months, 5 months
Comparison of glucose level
Discomfort related to metformin side effects
时间窗: Baseline, 2 months, 3 months, 5 months
Based on questionnaire
Insulin level
时间窗: Baseline, 2 months, 3 months, 5 months
Comparison of insulin level
次要结局
- HbA1c level(Baseline, 2 months, 3 months, 5 months)
- hsCRP level(Baseline, 2 months, 3 months, 5 months)
- Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)(Baseline, 2 months, 3 months, 5 months)