NCT01143948

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 15, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

June 10, 2010

Last Update Submit

June 14, 2010

Conditions

Type 2 DiabetesLiver Cirrhosis

Keywords

DiabetesCirrhosisInsulinInpatient

Outcome Measures

Primary Outcomes (1)

  • optimal glycemic control in inpatient cirrhotics

    3-7 days

Secondary Outcomes (1)

  • Incidence of hypoglycemic episodes

    3-7 days

Study Arms (3)

15 patient sliding scale regular insulin

ACTIVE COMPARATOR
Drug: Regular insulin

15 patient BBI NPH plus regular insulin

ACTIVE COMPARATOR
Drug: NPH & regular insulin

15 patients BBI Glargine plus Glulisine

ACTIVE COMPARATOR
Drug: Glargine & Glulisine

Interventions

Glargine & GlulisineDRUG

Basal Glargine \& bolus Glulisine

Also known as: lantus, apidra
15 patients BBI Glargine plus Glulisine
Regular insulinDRUG

Sliding scale regular insulin

Also known as: actrapid
15 patient sliding scale regular insulin
NPH & regular insulinDRUG

Basal NPH \& bolus regular insulin

Also known as: mixtard
15 patient BBI NPH plus regular insulin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hospitalized type 2 Diabetes Mellitus with liver cirrhosis
  • Entry blood glucose (fasting or random) greater than 180 mg%

You may not qualify if:

  • Type 1 Diabetes Mellitus
  • Pregnancy
  • Steroids: prednisone greater than 7.5mg/day or equivalent
  • Serum Creatinine \> 3 mg/dl
  • Patients in intensive care units.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal medicine hospital ,Cairo University

Cairo, Cairo Governorate, 11956, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 2037851BACKGROUND

  • 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.

    PMID: 10332677BACKGROUND

  • 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.

    PMID: 17327353RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Liver CirrhosisDiabetes MellitusFibrosisInsulin Resistance

Interventions

Insulin Glargineinsulin glulisineInsulininsulin, pork; isophane insulin, pork drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Ibtisam Z Eissa, MD

    Cairo University

    STUDY CHAIR

  • Mary N Rizk, MD

    Cairo Univerity

    STUDY DIRECTOR

  • Ahmad A Khairy, MD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mostafa M Alfishawy, MB BCh

CONTACT

0111183371mostafa.alfishawy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 15, 2010

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

June 15, 2010

Record last verified: 2010-02

Locations

EG(1)