Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2, a Pilot Clinical Trial Clinical Study Protocol

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.

Inclusion Criteria: 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) Exclusion Criteria: 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