Glucose lowering by continuous tube feeding and Vildagliptin in addition to insulin in hyperglycemic acute stroke patients.

Phase 4

Conditions: cerebral infarction
glucose control
stroke
high glucose
10018424
10007963

Registration Number: NL-OMON33687

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1) Supra-tentorial stroke with a time of onset within 24h before presentation.
2) An acute neurological deficit measurable with the National Institute of Health Stroke Score (NIHSS, see appendix I) >= 4 at presentation.
3) Venous plasma admission glucose > 7.0 mmol/l
4) Informed consent.

Exclusion Criteria

1) Signs of cerebral hemorrhage on computed tomography scan
2) Previous history of diabetes mellitus treated with insulin
3) Patients in whom death appears imminent
4) Renal insufficiency defined as creatinine > 150 mmol/L
5) Patients under the age of 18
6) Pregnant patients
7) Expected transfer to a different hospital within 5 days.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study has two primary endpoints<br /><br>• 1) Glycemic control.<br /><br>a) Mean glucose throughout protocol treatment<br /><br>b) Percentage of time spent within target range.<br /><br>• 2) Hypoglycemia<br /><br>a) The total number of hypoglycemic events per group.<br /><br>Hypoglycemia will be defined as any glucose value below 3.5 mmol/L.<br /><br>b) Number of of serious hypoglycemic events (glucose value below 2.2<br /><br>mmol/L)<br /><br>c) Number of symptomatic confirmed events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Clinical outcome:<br /><br>o Modified Rankin Score at three months follow-up (see appendix IV).<br /><br>• Occurrence of pneumonia<br /><br>• Treatment data:<br /><br>o Total insulin dose U/dy en U/kg/dy<br /><br>o Total amount of tube feeding administered<br /><br>o Number of sensors inserted per patient<br /><br>o Coefficient of Variation of CGMS derived glucose values<br /><br>o Accuracy of FreeStyle Navigator, expressed as Mean Absolute Difference vs.<br /><br>verification samples</p><br>