Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Keywords

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Inflammation Urea synthesis Catabolism Nitrogen balance

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Active inflammatory bowel disease

Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe active inflammatory bowel disease

Exclusion Criteria

* Viral or bacterial infections
* Other chronical inflammatory diseases
* Cancer
* Other catabolic diseases
* Treatment with prednisolone or infliximab within the last 8 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Karen Louise Thomsen

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Louise Thomsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Medicine V, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Hjortebjerg R, Thomsen KL, Agnholt J, Frystyk J. The IGF system in patients with inflammatory bowel disease treated with prednisolone or infliximab: potential role of the stanniocalcin-2 / PAPP-A / IGFBP-4 axis. BMC Gastroenterol. 2019 Jun 3;19(1):83. doi: 10.1186/s12876-019-1000-6.

Reference Type DERIVED

PMID: 31159802 (View on PubMed)

Other Identifiers

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FHNC-KLT

Identifier Type: -

Identifier Source: org_study_id