| - candidate number | 2446 |
| - NTR Number | NTR891 |
| - ISRCTN | incomplete |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 6-feb-2007 |
| - Secondary IDs | 1 |
| - Public Title | Diagnosis of cystic fibrosis fat malabsorption: fat absorption test. |
| - Scientific Title | Diagnostic test for cystic fibrosis related fat malabsorption: fecal fat balans or double labeled fat absorption test. |
| - ACRONYM | DLLT |
| - hypothesis | The double labeled triglyceride and free fatty acid fat absorption test is as effective as the fecal fat balance as a quantitative diagnostic test for intestinal fat absorption in CF patients. |
| - Healt Condition(s) or Problem(s) studied | Cystic fibrosis in children, Fat malabsorption, Fecal fat balans, Pancreatic insuffiency, Lipolysis |
| - Inclusion criteria | 1. Cystic fibrosis patients; 2. Age: 2 -18 years; 3. Pancreatic insufficiency. |
| - Exclusion criteria | 1. Cystic fibrosis related liver disease; 2. Pulmonary (non-)infectious exacerbation; 3. Use of gastric acid-suppressive medications. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | [default] |
| - control | [default] |
| - group | [default] |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-sep-2008 |
| - Target number of participants | 35 |
| - Interventions | N/A |
| - Primary outcome | 1. Fecal fat absorption coeficient; 2. Serum isotopes concentrations and appearance curves. |
| - Secondary outcome | N/A |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Drs. F.A.J.A. Bodewes |
| - CONTACT for SCIENTIFIC QUERIES | Drs. F.A.J.A. Bodewes |
| - Sponsor/Initiator | |
| - Funding (Source(s) of Monetary or Material Support) | |
| - Publications | 1. Rings EH, Minich DM, Vonk RJ, Stellaard F, Fetter WP, Verkade HJ.
Pediatr Res. 2002 Jan;51(1):57-63.
Functional development of fat absorption in term and preterm neonates strongly correlates with ability to absorb long-chain Fatty acids from intestinal lumen; 2. Kalivianakis M, Minich DM, Bijleveld CM, van Aalderen WM, Stellaard F, Laseur M, Vonk RJ, Verkade HJ. Am J Clin Nutr. 1999 Jan;69(1):127-34. Fat malabsorption in cystic fibrosis patients receiving enzyme replacement therapy is due to impaired intestinal uptake of long-chain fatty acids. Bijvelds MJ, Bronsveld I, Havinga R, Sinaasappel M, de Jonge HR, Verkade HJ Am J Physiol Gastrointest Liver Physiol. 2005 Apr;288(4):G646-53. Fat absorption in cystic fibrosis mice is impeded by defective lipolysis and post-lipolytic events |
| - Brief summary | The fecal fat balance is the current gold standard for evaluating fat malabsorption in CF patients. However there is a need for a simpler, sensitive and less restraining test to determine fat absorption in CF patients. More insight in the relative contribution of lipolysis and intestinal malabsorption of free fatty acids to fat malabsorption in CF patients would give way for a more directed therapeutic approach. The aim if the this study is to proof that the double labeled triglyceride and free fatty acid fat absorption test is as effective as the fecal fat balance as a quantitative diagnostic test for intestinal fat absorption in CF patients. In the study we use triglyceride and free fatty acid both labeled with a different stable isotope. The double labeled triglyceride and free fatty acid fat absorption test is based principle of simultaneous admission of both the labeled triglyceride and labeled free fatty acids. The resulting appearance curve in the plasma determines the absorption of the separate components and is an indication for intestinal fat absorption. |
| - Main changes (audit trail) | |
| - RECORD | 6-feb-2007 - 28-apr-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl