Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

NCT ID: NCT01143948

Last Updated: 2010-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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15 patient sliding scale regular insulin

Group Type ACTIVE_COMPARATOR

Regular insulin

Intervention Type DRUG

Sliding scale regular insulin

15 patient BBI NPH plus regular insulin

Group Type ACTIVE_COMPARATOR

NPH & regular insulin

Intervention Type DRUG

Basal NPH \& bolus regular insulin

15 patients BBI Glargine plus Glulisine

Group Type ACTIVE_COMPARATOR

Glargine & Glulisine

Intervention Type DRUG

Basal Glargine \& bolus Glulisine

Interventions

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Glargine & Glulisine

Basal Glargine \& bolus Glulisine

Intervention Type DRUG

Regular insulin

Sliding scale regular insulin

Intervention Type DRUG

NPH & regular insulin

Basal NPH \& bolus regular insulin

Intervention Type DRUG

Other Intervention Names

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lantus apidra actrapid mixtard

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Cairo University

Principal Investigators

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Ibtisam Z Eissa, MD

Role: STUDY_CHAIR

Cairo University

Mary N Rizk, MD

Role: STUDY_DIRECTOR

Cairo Univerity

Ahmad A Khairy, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Internal medicine hospital ,Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mostafa M Alfishawy, MB BCh

Role: CONTACT

0111183371

References

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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.

Reference Type BACKGROUND
PMID: 2037851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10332677 (View on PubMed)

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.

Reference Type RESULT
PMID: 17327353 (View on PubMed)

Other Identifiers

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LC-T2D

Identifier Type: -

Identifier Source: org_study_id

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