Effect of Dihydromirycetin Administration on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fasting glucose
研究概览
简要总结
Dihydromyricetin has demonstrated promising effects in glycemic control, insulin sensitivity and insulin secretion, that above mentioned findings show that dihydromyricetin has an excellent potential effect in the treatment of type 2 diabetes mellitus patients.
详细描述
A double-blind, randomized clinical trial of three pharmacological groups in 36 patients with a diagnosis of type 2 diabetes mellitus in accordance with the American Diabetes Association (ADA) without treatment.
They will be assigned randomly two groups of 12 patients, each one will receive dihydromyricetin 300 mg or metformin 850 mg, two times per day before having break-fast and before having dinner during 12 weeks.
The Area Under the Curve of glucose and insulin will be calculated, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both sexes
- •Age between 30 and 60 years
- •Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dL; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl; or glycosylated hemoglobin between >6.5%)
- •Informed consent signed
排除标准
- •Women with confirmed or suspected pregnancy, or under lactation and/or puerperium
- •Previous treatment for glucose
- •Fasting glucose ≥250 mg/dL
- •Body Mass Index ≥34.9 kg/m2
- •Known uncontrolled renal, hepatic, heart or thyroid diseased
- •Hypersensibility to ingredients of intervention
- •Triglycerides ≥500 mg/dL
- •Total cholesterol ≥240 mg/dL
- •Blood Pressure ≥140/90 mmHg
研究组 & 干预措施
Dihydromyricetin
Dihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
干预措施: Dihydromyricetin (Drug)
Metformin
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
Fasting glucose
时间窗: Baseline to Week 12
Changes in fasting glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.
Insulin sensitivity
时间窗: Baseline to Week 12
Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.
Postprandial glucose
时间窗: Baseline to Week 12
Changes in postprandial glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12.
Glycosylated hemoglobin
时间窗: Baseline to Week 12
Changes in glycosylated hemoglobin (A1C) after 12 weeks of intervention with dihydromyricetin and metformin. Glycosylated hemoglobin will be evaluated at baseline and week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12.
Total insulin secretion
时间窗: Baseline to Week 12
Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.
First phase of insulin secretion
时间窗: Baseline to Week 12
The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12.
次要结局
- Waist Circumference(Baseline to Week 12)
- Body Mass Index(Baseline, week 4, week 8 and week 12)
- C reactive protein(Baseline to Week 12)
- Body Weigh(Baseline, week 4, week 8 and week 12)
- Interleukin 6(Baseline to Week 12)
- Total Cholesterol(Baseline to Week 12)
- High Density Lipoprotein (c-HDL) levels(Basline to Week 12)
- Triglycerides levels(Baseline to Week 12)
- Low Density Lipoproteins (c-LDL) levels(Baseline to Week 12)
- Creatinine levels(Baseline to Week 12)
- Aspartate aminotransferase (AST) levels(Baseline to Week 12)
- Alanine aminotransferase (ALT) levels(Baseline to Week 12)
- Blood pressure(Baseline to Week 12)
研究者
Karina Griselda Pérez Rubio
Principal Investigator
University of Guadalajara