Efficacy and tolerability of horse chestnut seed extract to improve microcirculation in diabetic patients: a placebo-controlled, randomised, double-blind, crossover, single-centre, pilot study
- Conditions
- Type 2 diabetes mellitus on stable oral anti-diabetic treatment
- Registration Number
- DRKS00031074
- Lead Sponsor
- Cesra Arzneimittel GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
•Subjects of any sex (at least 25% men or women)
•Willing to provide personally written informed consent
•At least 18 years of age at time of consent
•Willing and able to understand the nature, significance and consequences of the clinical trial
•have type 2 diabetes with stable anti-diabetic treatment (no change in dose or composition over the last three months)
•have a stable treatment for all concomitant diseases (no change in dose or composition over the last three months)
•Body Mass Index (BMI) >35 kg/m²
•HbA1C >7.5%
•Subjects who have participated in an interventional clinical research study within the previous 3 months.
•Subjects who are taking bolus-insulin or sulfonylurea drugs as anti-diabetic medication or PII treatment within the previous 3 months.
•Subjects with regular or occasional intake of herbal vasoactive drugs (e.g. HCSE, Ginkgo, Ginseng, red wine leaves, diosmin/hesperidin)
•Subjects with occasional intake of vasodilating drugs (Nitrates, ACE-inhibitors, alpha-blockers, phosphodiesterase inhibitors, Ca-antagonists, Minoxidil, Dihydralazin, Dihydroergotoxin, Pentoxifylin) or acetylsalicylic acid > 100 mg/d
•Subjects with occasional intake of vasoconstrictors (caffeine tablets, amphetamine, alpha-1-agonists, dopamine, ephedrine, norephedrine)
•Manifest neuropathy
•Smokers
•Pregnant or breast-feeding women
•Severe disease with expected life expectancy less than 2 years or at the investigator’s discretion
•Study site employees, or immediate family members of a study site or sponsor employee.
•Subjects with symptomatic malabsorption disorders (Crohn’s Disease, Colitis ulcerosa, lactose or gluten intolerance)
•Subjects with rheumatoid disorders
•Weight loss intervention or recent body weight change greater than 5 kg during last 3 months
•Known allergy to any component of the investigational product
•Blood donation within 4 weeks prior to Visit 1 or during the study
•Anticipating any planned changes in lifestyle and nutrition habits for the duration of the study
•Clinical or laboratory evidence of hepatic or renal dysfunction or disease at investigator’s discretion; laboratory evidence defined as any of the following parameters: ALAT, ASAT >3x ULN; eGFR < 30 mg/min/1.73 m2
•Subjects who have previously been enrolled in this study.
•Any subject who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures (e.g., cognitive impairment).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment induced changes from corresponding Baseline visit (visit 1 and visit 3) in the maximal microvascular blood flow after post-ischaemic reactive hyperaemia response (PRH) (arm), evaluated by the laser Doppler flowmeter (O2C) at 2 mm after 4 weeks of treatment with either verum or placebo (visit 2 and visit 4).
- Secondary Outcome Measures
Name Time Method