Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2
NCT ID: NCT04233658
Last Updated: 2020-01-22
Study Results
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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UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2020-05-31
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
3x2 capsules / day
Cynara Scolymus
Cynara Scolymus
3x2 capsules / day
Interventions
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Placebo
3x2 capsules / day
Cynara Scolymus
3x2 capsules / day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Stefan Fischli
OTHER
Responsible Party
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Stefan Fischli
Deputy Head Division of Endocrinology and Diabetes
Other Identifiers
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2020-17
Identifier Type: -
Identifier Source: org_study_id
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