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Status unknownNCT01721538SCENARIOUpdated Nov 4, 2012

Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

An interventional study of Weight reduction program and Lecture on healthy nutrition in Stroke and Obesity, sponsored by Philipps University Marburg. Status unknown at 1 site in Germany. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-11-04.

Sponsored by Philipps University Marburg · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Stroke
  • Obesity

Keywords

  • stroke
  • prevention
  • obesity
  • weight reduction
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Philipps University Marburg is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Therapy arm

    Non-drug therapeutic weight reduction program (15 weeks)

    Other: Weight reduction program

  • Placebo comparator
    Control arm

    Lecture on healthy nutrition (1 hour)

    Other: Lecture on healthy nutrition

Interventions

  • OtherWeight reduction program
  • OtherLecture on healthy nutrition
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. Functional outcome

    Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)

    Time frame: 18 months

  2. Cognitive deficits

    Cognitive deficits in terms of vascular dementia as measured by the Structural Interview for diagnosis of Alzheimer dementia and multi-infarct dementia (SIDAM), the Vascular Dementia Assessment Scale cognitive subscale (VADAS-Cog), Stroop test and the Trail Makin Test

    Time frame: 18 months

  3. Post stroke depression

    Post stroke depression as measured by Beck Depression Inventar (BDI II) and health-related quality of life (HrQoL) as measured by the EuroQol (EQ5D, visual analogue scale), Stroke Specific Quality of Life Scale, Stroke Impact Scale.

    Time frame: 18 months

  4. Severity of arterial hypertension, diabetes mellitus and hyperlipidemia

    Time frame: 18 months

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Study locations

1 of 1 sites recruiting
  • Department of Neurology, Philipps-University Marburg
    Marburg, Germany
    Recruiting
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References and documents

Publications

  • 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. PubMed 18703800 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01721538
Lead sponsor
Philipps University Marburg
Collaborators
Von Behring-Röntgen Foundation
Responsible party
Dr. Yaroslav Winter (Neurologist and Research Fellow, Philipps University Marburg) — Principal investigator
First posted
Nov 4, 2012
Start date
Oct 2012
Primary completion
Apr 2015 (estimated)
Completion
Apr 2015 (estimated)
Last update
Nov 4, 2012

Study contacts

Yaroslav Winter, MD
Contact
wintery@med.uni-marburg.de
00496421-5865200

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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