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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04233658

Enrollment

Registered

2020-01-18

Start date

2020-05-31

Completion date

2022-12-31

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGPlacebo

3x2 capsules / day

DRUGCynara Scolymus

3x2 capsules / day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026