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

June 14, 2010 updated by: Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11956
        • Internal medicine hospital ,Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 15 patient sliding scale regular insulin
Drug: Regular insulin
Sliding scale regular insulin
Other Names:
  • actrapid
ACTIVE_COMPARATOR: 15 patient BBI NPH plus regular insulin
Drug: NPH & regular insulin
Basal NPH & bolus regular insulin
Other Names:
  • mixtard
ACTIVE_COMPARATOR: 15 patients BBI Glargine plus Glulisine
Drug: Glargine & Glulisine
Basal Glargine & bolus Glulisine
Other Names:
  • apidra
  • lantus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (ESTIMATE)

June 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2010

Last Update Submitted That Met QC Criteria

June 14, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC-T2D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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