Clinical trial NCT01143948: Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial
Official title: Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Liver Cirrhosis
Keywords: Diabetes
Cirrhosis
Insulin
Inpatient
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: optimal glycemic control in inpatient cirrhotics
timeFrame: 3-7 days
Secondary outcomes:
measure: Incidence of hypoglycemic episodes
timeFrame: 3-7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Internal medicine hospital ,Cairo University
Study officials:
affiliation: Cairo University
name: Ibtisam Z Eissa, MD
role: STUDY_CHAIR
affiliation: Cairo Univerity
name: Mary N Rizk, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ahmad A Khairy, MD
role: STUDY_DIRECTOR
References:
citation: Balkau B, Eschwege E, Ducimetiere 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. doi: 10.1016/0895-4356(91)90209-r.
citation: 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. doi: 10.2337/diacare.22.5.756.
citation: Tolman KG, Fonseca V, Dalpiaz A, Tan MH. Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care. 2007 Mar;30(3):734-43. doi: 10.2337/dc06-1539. No abstract available.