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

NCT ID: NCT01378468

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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First Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with first ischemic stroke

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

Intervention Type OTHER

see Ebinger et al., IJS, 2010

Interventions

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

see Ebinger et al., IJS, 2010

Intervention Type OTHER

Other Intervention Names

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cream

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Martin Ebinger

PD Dr. med. Dr. phil.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Ebinger

Role: PRINCIPAL_INVESTIGATOR

CSB

Matthias Endres

Role: PRINCIPAL_INVESTIGATOR

CSB

Locations

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Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Ebinger M, Heuschmann PU, Jungehuelsing GJ, Werner C, Laufs U, Endres M. The Berlin 'Cream&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke. Int J Stroke. 2010 Apr;5(2):126-30. doi: 10.1111/j.1747-4949.2010.00399.x.

Reference Type BACKGROUND
PMID: 20446947 (View on PubMed)

Lange KS, Nave AH, Liman TG, Grittner U, Endres M, Ebinger M. Lipoprotein(a) Levels and Recurrent Vascular Events After First Ischemic Stroke. Stroke. 2017 Jan;48(1):36-42. doi: 10.1161/STROKEAHA.116.014436. Epub 2016 Nov 17.

Reference Type DERIVED
PMID: 27856951 (View on PubMed)

Batluk J, Leonards CO, Grittner U, Lange KS, Schreiber SJ, Endres M, Ebinger M. Triglycerides and carotid intima-media thickness in ischemic stroke patients. Atherosclerosis. 2015 Nov;243(1):186-91. doi: 10.1016/j.atherosclerosis.2015.09.003. Epub 2015 Sep 9.

Reference Type DERIVED
PMID: 26398290 (View on PubMed)

Leonards CO, Ipsen N, Malzahn U, Fiebach JB, Endres M, Ebinger M. White matter lesion severity in mild acute ischemic stroke patients and functional outcome after 1 year. Stroke. 2012 Nov;43(11):3046-51. doi: 10.1161/STROKEAHA.111.646554. Epub 2012 Aug 30.

Reference Type DERIVED
PMID: 22935398 (View on PubMed)

Other Identifiers

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2009-010356-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

The Berlin 'Cream&Sugar' Study

Identifier Type: -

Identifier Source: org_study_id

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