Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke

• Conditions: First Ischemic Stroke
• Interventions: Other: oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)

• Registration Number: NCT01378468
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Primary Completion: 2016-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 573

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
• Expected life expectancyr12 months
• Inability to sign informed consent
• Acute coronary syndrome
• Severe heart valve disorder
• Heart failure (NYHA III-IV)
• Severe infectious/rheumatic disease
• Sever metabolic disease
• No oral glucose tolerance test in case of known diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with first ischemic stroke	oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)	-

Primary Outcome Measures

Name	Time	Method
Recurrent Stroke	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 Outcome Measures

Name	Time	Method
MI	one year after first ischemic stroke	Myocardial infarction
death	one year after first ischemic stroke	cardiovascular death (death due to any cardiovascular or cerebrovascular event)
TIA	one year after first ischemic stroke	transient ischemic attack

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany