Clinical trial NCT01721538: Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction
Official title: Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Obesity
Keywords: stroke
prevention
obesity
weight reduction
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Von Behring-Röntgen Foundation
First posted: 2012-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ischemic stroke
* 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:

* Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
* 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

Primary outcomes:
measure: The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
timeFrame: 18 months
Secondary outcomes:
measure: Functional outcome
timeFrame: 18 months
measure: Cognitive deficits
timeFrame: 18 months
measure: Post stroke depression
timeFrame: 18 months
measure: Severity of arterial hypertension, diabetes mellitus and hyperlipidemia
timeFrame: 18 months
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Neurology, Philipps-University Marburg
Study officials:
References:
citation: 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.