Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2, a Pilot Clinical Trial Clinical Study Protocol
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 主要终点
- Change of HbA1c-level from baseline to week 12
研究概览
简要总结
Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes.
The primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old.
- •Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening
- •HbA1c-level between 6.5-9%
- •Body mass index of ≥ 28 kg/m2
- •Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor)
排除标准
- •Subjects with diabetes mellitus type 1 or history of ketoacidosis,
- •Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l)
- •Use of insulin or GLP-1-receptor agonists
- •Women wanting to become pregnant
- •Pregnant or breast-feeding women
- •Known hepatic disorder
- •Severe renal insufficiency (GFR ≤30ml/min)
- •History of inflammatory bowel disease
- •History of gastric bypass or gastric sleeve surgery
- •Anticoagulation with vitamin K-antagonists
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Cynara Scolymus
干预措施: Cynara Scolymus (Drug)
结局指标
主要结局
Change of HbA1c-level from baseline to week 12
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Stefan Fischli
Deputy Head Division of Endocrinology and Diabetes
Luzerner Kantonsspital