Validation of two stable isotopic labels for determination of albumin synthesis rate

Completed

• Conditions: liver function / liver failure; Metabolic and Endocrine - Other metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12614000541606
• Lead Sponsor: Jan Wernerman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

healthy volunteers

Exclusion Criteria

Age < 18 years
Participation in other trial within 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
albumin synthesis rate<br><br>Albumin fractional synthesis rate is assessed by the flooding technique (Ballmer et al Am J Physiol 1990; 259: E797-803). The incorporation of labeled phenylalanine in plasma albumin is assessed by gas chromatography-mass spectrometry after separating albumin from other plasma proteins. The precursor pool is assessed from the ratio of labeled to unlabeled phenylalanine in plasma. [In the morning after start of infusion on each study occation. Volunteers will be studied twice (protocol 1) on day 1 and 3, or thrice on day 1, after 5 hrs and after 7 days (protocol 2).]

Secondary Outcome Measures

Name	Time	Method
Fibrinogen synthesis rate<br><br>Fibrinogen fractional synthesis rate is assessed by the flooding technique (Ballmer et al Am J Physiol 1990; 259: E797-803). The incorporation of labeled phenylalanine in plasma fibrinogen is assessed by gas chromatography-mass spectrometry after separating fibrinogen from other plasma proteins. The precursor pool is assessed from the ratio of labeled to unlabeled phenylalanine in plasma. [In the morning after start of infusion on each study occation. Volunteers will be studied twice (protocol 1) on day 1 and 3, or thrice on day 1, after 5 hrs and after 7 days (protocol 2).]