Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

Obesity Clinical Trial

— SCENARIO  

Official title:

Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01721538
• Other study ID #: SCENARIO OP1
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2012
• Last updated: November 2, 2012
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: November 2012
• Source: Philipps University Marburg Medical Center
• Contact: Yaroslav Winter, MD
• Phone: 00496421-5865200
• Email: wintery[@]med.uni-marburg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Stroke
• Weight Loss

Intervention

Other:
• Weight reduction program

• Lecture on healthy nutrition

Locations

Country	Name	City	State
Germany	Department of Neurology, Philipps-University Marburg	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Von Behring-Röntgen Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 months	No
Secondary	Functional outcome	Functional outcome as measured by the modified Rankin Scale (mRS), NIH Stroke Scale (NIHSS) and Barthel Index (BI)	18 months	No
Secondary	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	18 months	No
Secondary	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.	18 months	No
Secondary	Severity of arterial hypertension, diabetes mellitus and hyperlipidemia		18 months	No