THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT STUDY.

Not yet recruiting

• Conditions: liver cirrhosis; 10019654

• Registration Number: NL-OMON37474
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

18-70 years of age.;Liver cirrhosis.;Child Pugh score 6 or more.;Plasma IGF-I level below lower 2.5th percentile and adjusted for age (plasma IGF-I < -2 SD Z-score).;Willing and able to give informed consent.;Alcohol abstinence for at least 3 months before entering the study.;Eligible for liver transplantation, and being put on the liver transplant waiting list.

Exclusion Criteria

Tense ascites requiring repeated paracenteses (two or more in the preceding year).;Severe peripheral edema.;Hospitalization for gastrointestinal bleeding, spontaneous bacterial peritonitis or other life-threatening complications within 3 months before entering the study.;Episode of encephalopathy requiring protein restriction, or hepatic encephalopathy that precludes participation.;Drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study ends when all 6 patients have been treated with rhIGF-I for 6 months.<br /><br>The nutritional status of the patients measured by body composition, liver<br /><br>function, respiratory quotient, resting energy metabolism and the quality of<br /><br>life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The study will also end if serious adverse events occur.</p><br>