Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

NCT ID: NCT04233658

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3x2 capsules / day

Cynara Scolymus

Group Type EXPERIMENTAL

Cynara Scolymus

Intervention Type DRUG

3x2 capsules / day

Interventions

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Placebo

3x2 capsules / day

Intervention Type DRUG

Cynara Scolymus

3x2 capsules / day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stefan Fischli

OTHER

Sponsor Role lead

Responsible Party

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Stefan Fischli

Deputy Head Division of Endocrinology and Diabetes

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2020-17

Identifier Type: -

Identifier Source: org_study_id

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