Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness: A study protocol
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Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness : A study protocol. / Nielsen, Rikke Lundsgaard; Bornæs, Olivia; Storgaard, Ida Klitzing; Kallemose, Thomas; Jørgensen, Lillian Mørch; Jawad, Baker Nawfal; Altintas, Izzet; Juul-larsen, Helle Gybel; Tavenier, Juliette; Durhuus, Jon Ambæk; Bengaard, Anne Kathrine Pedersen; Holst, Jens Juul; Kolko, Miriam; Sonne, David Peick; Breindahl, Torben; Damgaard, Morten; Porrini, Esteban; Hornum, Mads; Andersen, Ove; Pedersen, Mette Merete; Rasmussen, Henrik Højgaard; Munk, Tina; Lund, Trine Meldgaard; Jensen, Ann Pia Søe Lytken; Andersen, Aino Leegaard; Houlind, Morten Baltzer.
In: Basic & Clinical Pharmacology & Toxicology, Vol. 133, No. 3, 2023, p. 237-253.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Appetite stimulation with cannabis-based medicine and methods for assessment of glomerular filtration in older patients with medical illness
T2 - A study protocol
AU - Nielsen, Rikke Lundsgaard
AU - Bornæs, Olivia
AU - Storgaard, Ida Klitzing
AU - Kallemose, Thomas
AU - Jørgensen, Lillian Mørch
AU - Jawad, Baker Nawfal
AU - Altintas, Izzet
AU - Juul-larsen, Helle Gybel
AU - Tavenier, Juliette
AU - Durhuus, Jon Ambæk
AU - Bengaard, Anne Kathrine Pedersen
AU - Holst, Jens Juul
AU - Kolko, Miriam
AU - Sonne, David Peick
AU - Breindahl, Torben
AU - Damgaard, Morten
AU - Porrini, Esteban
AU - Hornum, Mads
AU - Andersen, Ove
AU - Pedersen, Mette Merete
AU - Rasmussen, Henrik Højgaard
AU - Munk, Tina
AU - Lund, Trine Meldgaard
AU - Jensen, Ann Pia Søe Lytken
AU - Andersen, Aino Leegaard
AU - Houlind, Morten Baltzer
PY - 2023
Y1 - 2023
N2 - Background and aimMalnutrition in older patients is linked to poor appetite. Cannabis-based medicine may have orexigenic properties in older patients, but this has to our knowledge never been investigated. In older patients, uncertainty applies to the accuracy of estimated glomerular filtration rate (eGFR) based on creatinine, which is crucial for medication prescribing. In older patients with poor appetite, the study aims (1) to assess the efficacy of Sativex® (8.1-mg delta-9-tetrahydrocannabinol [THC] and 7.5-mg cannabidiol [CBD]) to stimulate appetite and (2) to compare the performance of various GFR-estimates and measured-GFR (mGFR) for determining gentamicin clearance utilizing population pharmacokinetic (popPK) modelling methods.Methods and objectivesThis study is composed of two substudies. Substudy 1 is an investigator-initiated single-center, double-blinded, randomized, placebo-controlled, superiority, cross-over study. Substudy 1 will recruit 17 older patients with poor appetite, who will also be invited to substudy 2. Substudy 2 is a single-dose pharmacokinetics study and will recruit 55 patients. Participants will receive Sativex® and placebo in substudy 1 and gentamicin with simultaneous measurements of GFR in substudy 2. The primary endpoints are as follows: Substudy 1—the difference in energy intake between Sativex® and placebo conditions; substudy 2— the 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.
AB - Background and aimMalnutrition in older patients is linked to poor appetite. Cannabis-based medicine may have orexigenic properties in older patients, but this has to our knowledge never been investigated. In older patients, uncertainty applies to the accuracy of estimated glomerular filtration rate (eGFR) based on creatinine, which is crucial for medication prescribing. In older patients with poor appetite, the study aims (1) to assess the efficacy of Sativex® (8.1-mg delta-9-tetrahydrocannabinol [THC] and 7.5-mg cannabidiol [CBD]) to stimulate appetite and (2) to compare the performance of various GFR-estimates and measured-GFR (mGFR) for determining gentamicin clearance utilizing population pharmacokinetic (popPK) modelling methods.Methods and objectivesThis study is composed of two substudies. Substudy 1 is an investigator-initiated single-center, double-blinded, randomized, placebo-controlled, superiority, cross-over study. Substudy 1 will recruit 17 older patients with poor appetite, who will also be invited to substudy 2. Substudy 2 is a single-dose pharmacokinetics study and will recruit 55 patients. Participants will receive Sativex® and placebo in substudy 1 and gentamicin with simultaneous measurements of GFR in substudy 2. The primary endpoints are as follows: Substudy 1—the difference in energy intake between Sativex® and placebo conditions; substudy 2— the 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.
U2 - 10.1111/bcpt.13914
DO - 10.1111/bcpt.13914
M3 - Journal article
C2 - 37314893
VL - 133
SP - 237
EP - 253
JO - Basic and Clinical Pharmacology and Toxicology
JF - Basic and Clinical Pharmacology and Toxicology
SN - 1742-7835
IS - 3
ER -
ID: 359136515