Clinical trial NCT01378468: Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
Official title: The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: First Ischemic Stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Hospital, Saarland
First posted: 2011-06-22
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population consists of adults with first ischemic stroke within the last three to seven days (at time of testing).

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.

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
* 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

Primary outcomes:
measure: Recurrent Stroke
timeFrame: outcome measure is assessed one year after first ischemic stroke.
Secondary outcomes:
measure: MI
timeFrame: one year after first ischemic stroke
measure: death
timeFrame: one year after first ischemic stroke
measure: TIA
timeFrame: one year after first ischemic stroke
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: CSB
name: Martin Ebinger
role: PRINCIPAL_INVESTIGATOR
affiliation: CSB
name: Matthias Endres
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.