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GLUCOVAS.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25157
Enrollment
30
Registered
2009-06-22
Start date
2009-07-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

1. IV insulin
2. Continuous tube feeding
3. Vildagliptin.

Sponsors

AMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Clinical outcome (modified Rankin score) at three months; 2. Incidence of pneumonia; 3. Treatment data.

Contacts

Public ContactNyika Kruyt

Academic Medical Center University of Amsterdam P.O. Box 22700

n.d.kruijt@amc.uva.nl+31 20 566 3547

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)