Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness: a study protocol.

R L Nielsen, O Bornaes, I K Storgaard,T Kallemose,L M Jørgensen,B N Jawad, I Altintas,H G Juul-Larsen,J Tavenier, J A Durhuus,A K P Bengaard,J J Holst,M Kolko,D P Sonne,T Breindahl,M Damgaard,E Porrini,M Hornum, O Andersen,M M Pedersen, H H Rasmussen, T Munk,T M Lund, P S Jensen,A L Andersen,M B Houlind

Basic & clinical pharmacology & toxicology(2023)

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摘要
This study is composed of two sub-studies. Sub-study 1 is an investigator-initiated single-center, double-blinded, randomised, placebo-controlled, superiority, cross-over study. Sub-study 1 will recruit 17 older patients with poor appetite, who will also be invited to sub-study 2. Sub-study 2 is a single-dose pharmacokinetics study and will recruit 55 patients. Participants will receive Sativex® and placebo in sub-study 1 and gentamicin with simultaneous measurements of GFR in sub-study 2. The primary endpoints are: sub-study 1) difference in energy intake between Sativex® and placebo conditions, and sub-study 2) accuracy of different eGFR equations compared to mGFR. The secondary endpoints include safety parameters, changes in the appetite hormones, total ghrelin and GLP-1 and subjective appetite sensations and the creation of popPK models of THC, CBD, and gentamicin.
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关键词
appetite, cannabis-based medicine, kidney function, older patients, renal risk drugs
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