The primary objective of this pilot study is to evaluate the effects of 6 months of recombinant human IGF-I (rhIGF-I) treatment on the body composition.The secondary objective is to assess the effects of the treatment on the liver function,…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study ends when all 6 patients have been treated with rhIGF-I for 6 months.
The nutritional status of the patients measured by body composition, liver
function, respiratory quotient, resting energy metabolism and the quality of
life.
Secondary outcome
The study will also end if serious adverse events occur.
Background summary
Insulin-like Growth Factor-I (IGF-I) is an anabolic hormone mainly produced in
the liver. Patients with liver cirrhosis are characterized by IGF-I deficiency
and malnutrition. There are studies that suggest that the suppletion of IGF-I
in patients with liver cirrhosis can improve their nutritional status.
Study objective
The primary objective of this pilot study is to evaluate the effects of 6
months of recombinant human IGF-I (rhIGF-I) treatment on the body composition.
The secondary objective is to assess the effects of the treatment on the liver
function, respiratory quotient, resting energy metabolism and the quality of
life.
Study design
Prospective open single-arm intervention study.
Intervention
The patients receive rhIGF-I 10 µg/kg twice daily as a subcutaneous injection
for 6 months.
Study burden and risks
The burdens associated with participation: 6 blood samples; 12 outpatient
clinic visits; 2 ward stay (1 stay of 2 days, 1 stay of 1 day); 7 history and
physical examination; 2 dietary consults; 2 DXA-scans; 7 'quality of life'
questionnaires; 2 indirect calorimetry; 2 handgrip strength and midarm muscle
circumference test; 2 24 hours urinary nitrogen excretion. The benefit for the
patients is an improved nutritional status which might lead to fewer
complications due to cirrhosis. There is a risk of hypoglycemia for the
patients that participate. However, careful preparations are taken to reduce
the frequency and severity of this risk.
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001239-30-NL |
| CCMO | NL40114.078.12 |