Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started May 2020
Longer than P75 for phase_3 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 22, 2020
January 1, 2020
2 years
January 15, 2020
January 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change of HbA1c-level from baseline to week 12
12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORCynara Scolymus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stefan Fischlilead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Head Division of Endocrinology and Diabetes
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
May 1, 2020
Primary Completion
May 1, 2022
Study Completion
December 1, 2022
Last Updated
January 22, 2020
Record last verified: 2020-01