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

January 30, 2017 updated by: Martin Ebinger, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

573

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with first ischemic stroke
Other: oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)
see Ebinger et al., IJS, 2010
Other Names:
  • cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Stroke
Time Frame: outcome 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.
outcome measure is assessed one year after first ischemic stroke.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MI
Time Frame: one year after first ischemic stroke
Myocardial infarction
one year after first ischemic stroke
death
Time Frame: one year after first ischemic stroke
cardiovascular death (death due to any cardiovascular or cerebrovascular event)
one year after first ischemic stroke
TIA
Time Frame: one year after first ischemic stroke
transient ischemic attack
one year after first ischemic stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

University Hospital, Saarland

Investigators

  • Principal Investigator: Martin Ebinger, CSB
  • Principal Investigator: Matthias Endres, CSB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (ESTIMATE)

June 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Berlin 'Cream&Sugar' Study
  • 2009-010356-97 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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