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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Cynara Scolymus

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 3x2 capsules / day
Experimental: Cynara Scolymus	Drug: Cynara Scolymus; 3x2 capsules / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of HbA1c-level from baseline to week 12	12 weeks

Collaborators and Investigators

• Sponsor: Stefan Fischli

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2020-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No