Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

Phase 3

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Cynara Scolymus

• Registration Number: NCT04233658
• Lead Sponsor: Stefan Fischli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-22
• Study Start: 2020-05
• Primary Completion: 2022-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cynara Scolymus	Cynara Scolymus	-

Primary Outcome Measures

Name	Time	Method
Change of HbA1c-level from baseline to week 12	12 weeks