Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04233658
• Other study ID #: 2020-17
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2020
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
3x2 capsules / day
• Cynara Scolymus
3x2 capsules / day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stefan Fischli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c-level from baseline to week 12		12 weeks