VIRDICT: Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 15 patient sliding scale regular insulin
|
Drug: Regular insulin
Sliding scale regular insulin
Other Names:
|
| Active Comparator: 15 patient BBI NPH plus regular insulin
|
Drug: NPH & regular insulin
Basal NPH & bolus regular insulin
Other Names:
|
| Active Comparator: 15 patients BBI Glargine plus Glulisine
|
Drug: Glargine & Glulisine
Basal Glargine & bolus Glulisine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- optimal glycemic control in inpatient cirrhotics [3-7 days]
Secondary Outcome Measures
- Incidence of hypoglycemic episodes [3-7 days]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Internal medicine hospital ,Cairo University | Cairo | Egypt | 11956 |
Sponsors and Collaborators
- Cairo University
- Sanofi
Investigators
- Study Chair: Ibtisam Z Eissa, MD, Cairo University
- Study Director: Mary N Rizk, MD, Cairo Univerity
- Study Director: Ahmad A Khairy, MD, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
- Balkau B, Eschwège E, Ducimetière P, Richard JL, Warnet JM. The high risk of death by alcohol related diseases in subjects diagnosed as diabetic and impaired glucose tolerant: the Paris Prospective Study after 15 years of follow-up. J Clin Epidemiol. 1991;44(6):465-74.
- de Marco R, Locatelli F, Zoppini G, Verlato G, Bonora E, Muggeo M. Cause-specific mortality in type 2 diabetes. The Verona Diabetes Study. Diabetes Care. 1999 May;22(5):756-61.
- LC-T2D