Efficacy and Safety of Mulberry Leaves on Glycemic Control in Patients With Obesity and Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy)
研究概览
简要总结
A 12-week, open-label, randomized, controlled trial investigating effect of mulberry leaves plus lifestyle intervention on glycemic control compare with lifestyle intervention alone in patients with obesity and patients with type 2 diabetes (T2DM)
详细描述
Diabetes remains a common leading cause of morbidity and mortality among population worldwide over decades. Obesity, a crucial risk factors for developing T2DM, commonly exists with insulin resistance and impaired beta-cell function. Early management in individuals at high risk of T2DM should be therefore considered for preventing or delaying the progression of diabetes and diabetic complications.
Since 1-deoxynojirimycin (DNJ), the major antihyperglycemic compound of mulberry leaves, inhibits alpha-glucosidase activities, ingestion of mulberry leaves results in the suppression of postprandial hyperglycemia. Long-term effects of mulberry leaves on glycemic profiles have been demonstrated in numerous clinical studies; however, the results were controversial. In addition, no study was conducted in patients with obesity. As a result, this open-label, randomized controlled study aims to investigate efficacy and safety of mulberry leaves in combination with lifestyle intervention (diet control) on glycemic control in non-diabetic patients with obesity and patients with early-stage T2DM. Efficacy of the interventions will be assessed based on the changes in glycemic indexes, expression of proteins related to insulin resistance and T2DM, and lipid profiles. Meanwhile, safety will be measured by the changes in renal and hepatic enzymes and patient-self reports. The outcomes will be monitored at 4-week interval throughout 12 weeks of the study period.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men age 20-65 years
- •Have 1 of 3 characteristics as follows;
- •Non-diabetic obese patients (BMI ≥25 kg/m2)
- •Patients with T2DM: drug naïve and newly diagnosed within 6 months before study enrollment
- •Patients with T2DM: inadequate control (A1c ≥7%, but not >8%) with metformin therapy (>1,000 mg/day) alone at least 3 months before study enrollment
- •Well communicate in the Thai language
排除标准
- •Allergy to mulberry leaves products
- •FPG ≥180 mg/dL
- •AST and ALT >40 U/L
- •Cr <0.6 or >1.2 mg/dL
- •BUN >20 mg/dL
- •Existing or having history of gastrointestinal surgery or abnormal conditions affecting digestion and intestinal absorption
- •Existing or having history of hematological disorders, thyroid diseases, CVD, ischemic stroke, CKD, or other uncontrolled and life-threatening conditions
- •Presence of significant diabetic complications
- •Taking drugs, supplements, and herbs affecting blood glucose level: corticosteroids, second-generation antipsychotics, niacin, thiazide diuretics, and ß-blockers, within 1 month before study enrollment
- •Taking unnecessary drugs, supplements, and herbs affecting lipid level within 1 month before study enrollment
- •Women during pregnancy or lactation
结局指标
主要结局
Effect on 2-hour postprandial glucose (PPG) during 75-g oral glucose tolerance test (OGTT) (efficacy)
时间窗: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of the 2-hour PPG (in mg/dL) during 75-g OGTT at week 12
Effect on fasting plasma glucose (FPG) (efficacy)
时间窗: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of FPG (in mg/dL) at week 4, 8, and 12
Effect on glycated hemoglobin (A1C) (efficacy)
时间窗: 12 weeks
To evaluate difference between the treatment group and the control group, and change from baseline of A1C (in %) at week 12
次要结局
- Effect on triglycerides (efficacy)(12 weeks)
- Effect on total cholesterol (efficacy)(12 weeks)
- Effect on high-density lipoprotein cholesterol (HDL-C) (efficacy)(12 weeks)
- Effect on insulin resistance index (efficacy)(12 weeks)
- Adverse effects on renal function (safety)(12 weeks)
- Effect on low-density lipoprotein cholesterol (LDL-C) (efficacy)(12 weeks)
- Adverse effects on hepatic function 1 (safety)(12 weeks)
- Adverse effects on hepatic function 2 (safety)(12 weeks)
- Self-reported adverse events (safety)(12 weeks)
研究者
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University