First Ischemic StrokeNCT01378468
Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
An observational study of First Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Ischemic Stroke
- What is being tested?
- oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)
- Type of treatment
- Pill or oral medicine
- How many people
- 573 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the study population consists of adults with first ischemic stroke within the last three to seven days (at time of testing).
Who may be able to join
- Age over 18 years
- First ischemic stroke
- Incidence within less than 7 days
- Informed consent obtained
Who cannot join
- Aphasia (if hampering informed consent)
- Swallowing disorder
- Pregnancy
- Renal or hepatic failure
- Pancreatitis
- Cholecystolithiasis
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- First Ischemic Stroke
- Being tested
- oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)Other
Also called cream
see Ebinger et al., IJS, 2010
| Study group | Role | What they receive |
|---|---|---|
| Patients with first ischemic stroke | Not described Receives: Other: oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Stroke
The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event.
Measured: outcome measure is assessed one year after first ischemic stroke.
Secondary outcomes (3)
MI
Myocardial infarction
Measured: one year after first ischemic stroke
death
cardiovascular death (death due to any cardiovascular or cerebrovascular event)
Measured: one year after first ischemic stroke
TIA
transient ischemic attack
Measured: one year after first ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2016
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for First Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Saarland
- Responsible party
- Principal investigator, Martin Ebinger, Charite University, Berlin, Germany
- Investigators
- Martin Ebinger, Principal investigator, Clínica Sebastián de BelalcázarMatthias Endres, Principal investigator, Clínica Sebastián de Belalcázar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378468
- Sponsor's protocol ID
- The Berlin 'Cream&Sugar' Study
- Other IDs
- 2009-010356-97, 2009
- Status last verified
- Jan 2017
- First submitted
- 21 Jun 2011
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20446947Lange 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.
PubMed 27856951Batluk 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.
PubMed 26398290Leonards 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.
PubMed 22935398
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01378468
- Acronym / sponsor ID
- The Berlin 'Cream&Sugar' Study
- Conditions
- First Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Hospital, Saarland
- Study start
- Jan 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with first ischemic stroke | – | Other: oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the study population consists of adults with first ischemic stroke within the last three to seven days (at time of testing).
Key inclusion criteria (4 listed)
- Age over 18 years
- First ischemic stroke
- Incidence within less than 7 days
- Informed consent obtained
Key exclusion criteria (18 listed)
- Aphasia (if hampering informed consent)
- Swallowing disorder
- Pregnancy
- Renal or hepatic failure
- Pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral triglyceride tolerance test (not a therapeutic "intervention" as such but a new diagnostic test)Also: creamsee Ebinger et al., IJS, 2010 | Other | Patients with first ischemic stroke |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 20446947Ebinger 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.
- Derived from this study: PubMed 27856951Lange 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.
- Derived from this study: PubMed 26398290Batluk 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.
- Derived from this study: PubMed 22935398Leonards 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Ebinger principal investigator
Clínica Sebastián de Belalcázar
Matthias Endres principal investigator
Clínica Sebastián de Belalcázar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Stroke (time frame: outcome measure is assessed one year after first ischemic stroke.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378468, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.