Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

Study Overview
=================
Brief Summary
-----------------
Liver disease is an important cause of death in type 2 diabetes. In the population-based Verona Diabetes Study cirrhosis was the fourth leading cause of death and accounted for 4.4% of diabetes-related deaths. In another prospective cohort study , cirrhosis accounted for 12.5% of deaths in patients with diabetes. In Egypt hepatitis C virus the commonest of cirrhosis here has a prevalence of 9.8% in the population with the greatest burden over national health care bills. Patients with cirrhosis & type 2 diabetes mellitus are always showing up in all hospital wards without a clear consensus of best management of their hyperglycemia.

Detailed Description
-----------------
Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH & regular insulin or Glargine & Glulisine.

Official Title
-----------------
Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Glargine & Glulisine
* Drug: Regular insulin
* Drug: NPH & regular insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized type 2 Diabetes Mellitus with liver cirrhosis Entry blood glucose (fasting or random) greater than 180 mg% Exclusion Criteria: Type 1 Diabetes Mellitus Pregnancy Steroids: prednisone greater than 7.5mg/day or equivalent Serum Creatinine > 3 mg/dl Patients in intensive care units.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 15 patient sliding scale regular insulin<br> | Drug: Regular insulin<br>* Sliding scale regular insulin<br>* Other names: actrapid;|
| Active Comparator: 15 patient BBI NPH plus regular insulin<br> | Drug: NPH & regular insulin<br>* Basal NPH & bolus regular insulin<br>* Other names: mixtard;|
| Active Comparator: 15 patients BBI Glargine plus Glulisine<br> | Drug: Glargine & Glulisine<br>* Basal Glargine & bolus Glulisine<br>* Other names: apidra;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal glycemic control in inpatient cirrhotics |  | 3-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycemic episodes |  | 3-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Cirrhosis, Insulin, Inpatient