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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01378468
Enrollment
573
Registered
2011-06-22
Start date
2009-01-31
Completion date
2017-07-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Ischemic Stroke

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.

Interventions

OTHERoral triglyceride tolerance test (not a therapeutic intervention as such but a new diagnostic test)

see Ebinger et al., IJS, 2010

Sponsors

University Hospital, Saarland
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrent Strokeoutcome 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

MeasureTime frameDescription
MIone year after first ischemic strokeMyocardial infarction
deathone year after first ischemic strokecardiovascular death (death due to any cardiovascular or cerebrovascular event)
TIAone year after first ischemic stroketransient ischemic attack

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026