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Clinical Trials/NCT01378468
NCT01378468
Unknown
Not Applicable

The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke

Charite University, Berlin, Germany1 site in 1 country573 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
First Ischemic Stroke
Sponsor
Charite University, Berlin, Germany
Enrollment
573
Locations
1
Primary Endpoint
Recurrent Stroke
Last Updated
9 years ago

Overview

Brief Summary

Non-fasting triglyceride levels are thought to play a role in stroke. The investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.

Detailed Description

Since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. Follow-up after one year primarily assesses wether or not a recurrent stroke has occured. The glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. Potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. For further details see Ebinger et al. 'The Berlin 'Cream\&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', IJS; 2010,5, 47-51.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
July 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Ebinger

PD Dr. med. Dr. phil.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • Age over 18 years
  • First ischemic stroke
  • Incidence within less than 7 days
  • Informed consent obtained

Exclusion Criteria

  • Aphasia (if hampering informed consent)
  • Swallowing disorder
  • Pregnancy
  • Renal or hepatic failure
  • Pancreatitis
  • Cholecystolithiasis
  • Malabsorption
  • Lactose intolerance
  • Psychosis
  • Drug and/or alcohol addiction

Outcomes

Primary Outcomes

Recurrent Stroke

Time Frame: outcome measure is assessed one year after first ischemic stroke.

The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event.

Secondary Outcomes

  • MI(one year after first ischemic stroke)
  • death(one year after first ischemic stroke)
  • TIA(one year after first ischemic stroke)

Study Sites (1)

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