Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction
NCT ID: NCT01721538
Last Updated: 2012-11-05
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
NA
200 participants
INTERVENTIONAL
2012-10-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Therapy arm
Non-drug therapeutic weight reduction program (15 weeks)
Weight reduction program
Control arm
Lecture on healthy nutrition (1 hour)
Lecture on healthy nutrition
Interventions
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Weight reduction program
Lecture on healthy nutrition
Eligibility Criteria
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Inclusion Criteria
* Age: 20 - 85 years
* BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
* Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
* Patient must be capable of understanding informed consent
* Written informed consent for participation in the study
Exclusion Criteria
* Speech disturbance (aphasia or sever dysarthria)
* Dimming of consciousness
* Stroke due to arterial dissection or coagulation disorder
* Drug-related weight changes during previous 3 months
* Changes in appetite influencing medication listed in appendix during previous 3 months
* Bariatric surgery in the past
* Diabetes mellitus with a history of severe ketoacidosis
* Pregnancy or nursing
* Severe co-morbid disorders, e.g.:
* AV-Block ≥ 2nd degree
* Heart insufficiency (NYHA \> 2)
* Pericarditis, pericardial effusion
* Severe kidney insufficiency (Creatinine \> 3 mg/dl; Urea \> 150 mg/dl)
* Hepatic insufficiency (GOT \> 3 x ULN; GPT \> 3 x ULN)
* Severe psychiatric disease within the last six months (psychosis, suicide attempts)
* Chronic alcohol addiction or drug addiction
* HIV- or hepatitis infection
* Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program)
* Cognitive impairment with MMSE \< 20
* Depression with BDI \> 20
* Patients who are unable to give consent to study participation (MMSE \< 20, aphasia)
* Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program
* Simultaneous participation in another clinical trial
20 Years
85 Years
ALL
No
Sponsors
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Von Behring-Röntgen Foundation
UNKNOWN
Philipps University Marburg
OTHER
Responsible Party
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Dr. Yaroslav Winter
Neurologist and Research Fellow
Locations
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Department of Neurology, Philipps-University Marburg
Marburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Winter Yaroslav, MD
Role: primary
References
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Winter Y, Rohrmann S, Linseisen J, Lanczik O, Ringleb PA, Hebebrand J, Back T. Contribution of obesity and abdominal fat mass to risk of stroke and transient ischemic attacks. Stroke. 2008 Dec;39(12):3145-51. doi: 10.1161/STROKEAHA.108.523001. Epub 2008 Aug 14.
Other Identifiers
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SCENARIO OP1
Identifier Type: -
Identifier Source: org_study_id