Overview

This trial is active, not recruiting.

Condition first ischemic stroke
Treatment oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)
Sponsor Charite University, Berlin, Germany
Collaborator University Hospital, Saarland
Start date January 2009
End date December 2016
Trial size 573 participants
Trial identifier NCT01378468, 2009-010356-97, The Berlin 'Cream&Sugar' Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test) cream
see Ebinger et al., IJS, 2010

Primary Outcomes

Measure
Recurrent Stroke
time frame: outcome measure is assessed one year after first ischemic stroke.

Secondary Outcomes

Measure
MI
time frame: one year after first ischemic stroke
death
time frame: one year after first ischemic stroke
TIA
time frame: one year after first ischemic stroke

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
Principal investigator Martin Ebinger
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.