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

First Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01378468
• Other study ID #: The Berlin 'Cream&Sugar' Study
• Secondary ID: 2009-010356-97
• Status: Active, not recruiting
• Phase: N/A
• First received: June 21, 2011
• Last updated: January 30, 2017
• Start date: January 2009
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 573
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• First Ischemic Stroke
• Ischemia
• Stroke

Intervention

Other:
• oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)
see Ebinger et al., IJS, 2010

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Stroke	The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event.	outcome measure is assessed one year after first ischemic stroke.
Secondary	MI	Myocardial infarction	one year after first ischemic stroke
Secondary	death	cardiovascular death (death due to any cardiovascular or cerebrovascular event)	one year after first ischemic stroke
Secondary	TIA	transient ischemic attack	one year after first ischemic stroke