Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia



Status:Recruiting
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:March 27, 2018
End Date:December 31, 2020
Contact:Mark E Molitch, MD
Email:molitch@northwestern.edu
Phone:312 503-4130

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Use of Neutral Protamine Hagedorn (NPH) Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Glucocorticoids are known to cause an increase in insulin resistance, leading to
hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and
outpatient setting, steroids are used for their anti-inflammatory property to treat a variety
of conditions. There is a paucity of information regarding the best way to treat
steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin,
an intermediate-acting insulin, given at the time of steroid administration to the patient's
standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen
which will consist primarily increasing the prandial doses at lunch and supper in order to
determine which regimen is superior for glycemic control.

Inpatients who will receive single daily doses of prednisone or methylprednisolone for
treatment of their underlying condition and who become hyperglycemic will be eligible.
Subjects will be randomized in a 1:1 fashion to one of two arms: (1) to their standard basal
bolus insulin the addition of NPH insulin given at the time of the steroid adminstration,
adjusting the dose based on the dose of steroid; (2) an increase in the basal and prandial
bolus insulin doses based on the dose of steroid. Glycemic control and the incidence of
hypoglycemia will be assessed over the first 3 days after initiating these insulin regimens.

Inclusion Criteria:

- Patients receiving once daily dosing of methylprednisolone or prednisone in a dose of
10 mg/day or greater

- Hyperglycemic (Glucose level > 126 mg/dL)

- Diabetic and nondiabetic patients

- Expected duration of hospital stay and time on steroids >= 3 days

- Patient of appropriate caregiver able to give Informed Consent

Exclusion Criteria:

- Patients with 2 or more doses of methylprednisolone/prednisone per day

- Steroids other than methylprednisolone or prednisone

- Pregnancy

- estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2
We found this trial at
1
site
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Phone: 312-695-1535
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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