NCT01396954

Brief Summary

Glucose metabolism disorders (GMD) can be present in an overt and a subclinical way. They have negative impact in survival of patients with liver cirrhosis (LC). Their prevalence has not been determined in compensated cirrhotic patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 19, 2011

Status Verified

November 1, 2007

Enrollment Period

3.8 years

First QC Date

July 18, 2011

Last Update Submit

July 18, 2011

Conditions

Glucose Metabolism Disorders

Keywords

Liver cirrhosisDiabetes mellitusHepatogenous diabetesOral glucose tolerance testInsulin resistance.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We prospectively included patients with compensated liver cirrhosis who were admitted in the Regional Center for the Study of Digestive Diseases and the Liver Unit of the University Hospital and Faculty of Medicine

You may not qualify if:

  • Patients with complications due to liver disease (such as hepatocellular carcinoma, alcoholic hepatitis, active gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and severe infection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose Metabolism DisordersLiver CirrhosisDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System DiseasesHyperinsulinism

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

November 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

July 19, 2011

Record last verified: 2007-11