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Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial (VIRDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01143948
Recruitment Status : Unknown
Verified February 2010 by Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2010
Last Update Posted : June 15, 2010
Information provided by:
Cairo University

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
Type 2 Diabetes Liver Cirrhosis Drug: Glargine & Glulisine Drug: Regular insulin Drug: NPH & regular insulin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Therapy in the Inpatient Management of Cirrhotic Patients With Type 2 Diabetes
Study Start Date : January 2011
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Active Comparator: 15 patient sliding scale regular insulin Drug: Regular insulin
Sliding scale regular insulin
Other Name: actrapid

Active Comparator: 15 patient BBI NPH plus regular insulin Drug: NPH & regular insulin
Basal NPH & bolus regular insulin
Other Name: mixtard

Active Comparator: 15 patients BBI Glargine plus Glulisine Drug: Glargine & Glulisine
Basal Glargine & bolus Glulisine
Other Names:
  • lantus
  • apidra

Primary Outcome Measures :
  1. optimal glycemic control in inpatient cirrhotics [ Time Frame: 3-7 days ]

Secondary Outcome Measures :
  1. Incidence of hypoglycemic episodes [ Time Frame: 3-7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01143948

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Contact: Mostafa M Alfishawy, MB BCh 0111183371

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Internal medicine hospital ,Cairo University Active, not recruiting
Cairo, Egypt, 11956
Sponsors and Collaborators
Cairo University
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Study Chair: Ibtisam Z Eissa, MD Cairo University
Study Director: Mary N Rizk, MD Cairo Univerity
Study Director: Ahmad A Khairy, MD Cairo University

Publications of Results:
Other Publications:
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Responsible Party: Internal Medicine Department, Cairo University Identifier: NCT01143948     History of Changes
Other Study ID Numbers: LC-T2D
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: February 2010
Keywords provided by Cairo University:
Additional relevant MeSH terms:
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Liver Cirrhosis
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs