|- candidate number||6005|
|- NTR Number||NTR1874|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jun-2009|
|- Secondary IDs||08/382 METC AMC|
|- Public Title||GLUCOVAS.|
|- Scientific Title||Glucose regulation by continuous tube feeding and Vildagliptin in addition to insulin in hyperglycemic acute stroke patients. |
|- hypothesis||1. TGC with insulin in continuous tube fed patients is superior to TGC with insulin in regularly fed patients;|
2. Vildagliptin as add-on therapy to insulin mediated TGC results in less hypoglycemic episodes compared to placebo.
|- Healt Condition(s) or Problem(s) studied||Hyperglycemia, Acute ischemic stroke|
|- 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 (see appendix I, NIHSS score) ¡Ý 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-jul-2009|
|- planned closingdate||10-aug-2009|
|- Target number of participants||30|
|- Interventions||1. IV insulin;|
2. Continuous tube feeding;
|- Primary outcome||1. Glycemic control. (Mean glucose throughout protocol treatment; Percentage of time spent within target range);|
2. Hypoglycemia (glucose <3.5 mmol/L): Number of hypoglycemic events per group, Number of serious hypoglycemic events (glucose<2.2 mmol/L), Number of symptomatic confirmed hypoglycemic events.
|- Secondary outcome||1. Clinical outcome (modified Rankin score) at three months;|
2. Incidence of pneumonia;
3. Treatment data.
|- Timepoints||1. 5 days;|
2. 3 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD Nyika Kruyt|
|- CONTACT for SCIENTIFIC QUERIES||MD Nyika Kruyt|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Hyperglycemia has been associated with poor clincal outcome in patients with acute ischemic stroke. Therefore, glycemic control has the potential to improve clinical outcome. Glycemic control, however, appears to be difficult to establish due to postprandial glucose surges and an increased number of hypoglycemic episodes. With this study we investigate if (i) glycemic control in continuous tube fed patients is superior compared to regularly fed patients and (ii) If vildagliptin as add-on therapy to insulin results in less hypoglycemic episodes compared to placebo.|
|- Main changes (audit trail)|
|- RECORD||22-jun-2009 - 6-okt-2009|