Effect of Metformin Glycinate on Postprandial Lipemia, Glycemic Control and Oxidation Markers in Type 2 Diabetes Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in postprandial lipemia at 4 months
研究概览
简要总结
The aim of this study is to evaluate the effect of metformin glycinate vs metformin hydrochloride on postprandial lipemia. 72 patients will be included, they will be randomized and assigned into one of the two treatment groups: metformin glycinate 1240 mg BID or metformin hydrochloride 1000 mg BID (36 patients per group). The patients will be followed for 4 months.
Blood count, blood chemistry, liver profile, lipid profile, HbA1c, apolipoprotein B, oxidized LDL, fibroblast growth factor 21, leptin, adiponectin, C-reactive protein, free fatty acids, fibrinogen, Goodpasture Binding Protein (GPBP) and antioxidant activity of plasma will be measured at baseline and 4 months.
Additionally, after a structured meal, the following parameters will be measured: glucose, insulin, triglycerides, apolipoprotein B and oxidized LDL. (baseline and 4 months). Throughout the study adverse events will be documented.
详细描述
Main objective: To compare the effect of metformin glycinate with metformin hydrochloride postprandial lipemia (area under the curve of triglycerides)
Study group
Tablets of 620 mg of metformin glycinate. Scaling: 1 tablet at night for 3 days, followed by 1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets in the evening to complete the study. Final study dose 1240 mg every 12 hours.
Comparative group
500 mg tablets of metformin hydrochloride. Scaling: 1 tablet at night for 3 days, followed by 1 tablet in the morning and 1 tablet at night for 3 days, followed by 1 tablet in the morning and 2 tablets in the evening for 3 days and finally, 2 tablets in the morning and 2 tablets in the evening to complete the study. Final study dose 1000 mg every 12 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes
- •Between 35 and 65 years old
- •Patients with type 2 diabetes within two years of diagnosis according to the ADA criteria
- •Overweight patients (BMI between 25.5 and 29.9 kg/m2) or with grade 1 obesity (BMI between 30.0 and 34.9 kg/m2), according to WHO classification
- •Low HDL levels: <50 in women and <40 mg/dL in men
- •Hypertriglyceridemia: >150 and less than 300 mg/dL
- •Patients who had not taken antidiabetes drug treatment or with diet and exercise treatment, or with metformin or DPP4 inhibitor monotherapy
- •HbA1c between 6.5 and 8.5%.
- •Creatinine clearance >60 ml/min (calculated by Cockcroft and Gault)
- •Informed consent form signed.
- •Women using contraception.
排除标准
- •Patients with other types of diabetes (type 1, LADA, MODY, etc.).
- •Patients with primary dyslipidemia.
- •Patients with poorly substituted hypothyroidism TSH > 5 mU/mL.
- •Patients hospitalized in the last month.
- •Patients with a disease of poor short-term prognosis
- •Patients with autoimmune or rheumatic diseases.
- •Patients with acute infection or febrile illness.
- •History of chronic liver disease or ALT or AST ≥ 2.0 times the upper limit of normal, or GGT ≥ 3 times the upper limit of normal.
- •Patients with any other chronic disease, for example: HIV, rheumatic diseases.
- •Pregnant or positive pregnancy test.
- •Women who are breastfeeding.
- •Patients in another research project.
研究组 & 干预措施
metformin glycinate
620mg tablets of metformin glycinate: 1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study.
Total study dose: 1240mg every 12 hours.
干预措施: Metformin glycinate (Drug)
metformin hydrochloride
500mg tablets of metformin hydrochloride:1 tablet by mouth at night for 3 days, 1 tablet in the morning and evening for 3 days, 1 tablet in the morning and 2 tablets in the evening for 3 days and 2 tablets in the evening and 2 tablets in the morning until the end of the study.
Total study dose: 1000mg every 12 hours.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Change in postprandial lipemia at 4 months
时间窗: baseline, 4 months
次要结局
- Change in FGF-21 levels at 4 months(baseline, 4 months)
- Change in uric acid at 4 months(baseline, 4 months)
- Number of Participants with Serious and Non-Serious Adverse Events(up to 4 months)
- Change in oxidized LDL at 4 months(baseline, 4 months)
- Change in A1C at 4 months(baseline, 4 months)
- Change in alanine aminotransferase at 4 months(baseline, 4 months)