Effect of Semaglutide on Physical Function, Body Composition, and Biomarkers of Aging in Older Adults With Overweight and Insulin Resistance: Protocol for an Open-Labeled Randomized Controlled Trial.
Humans
Body Composition
/ drug effects
Aged
Glucagon-Like Peptides
/ therapeutic use
Male
Biomarkers
/ blood
Female
Insulin Resistance
Overweight
/ drug therapy
Diabetes Mellitus, Type 2
/ drug therapy
Aging
/ drug effects
Hypoglycemic Agents
/ therapeutic use
Prediabetic State
/ drug therapy
Physical Functional Performance
biomarkers of aging
glucagon-like peptide
lean body mass
physical function
semaglutide
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
13 Sep 2024
13 Sep 2024
Historique:
received:
28
05
2024
accepted:
11
07
2024
revised:
01
07
2024
medline:
13
9
2024
pubmed:
13
9
2024
entrez:
13
9
2024
Statut:
epublish
Résumé
Older adults with type 2 diabetes mellitus (T2DM) or prediabetes are at increased risk of adverse changes in body composition, physical function, and aging-related biomarkers compared to those with normal glucose tolerance. Semaglutide is a glucagon-like peptide 1 receptor agonist that has been approved for T2DM and chronic weight management. Although semaglutide is effective for weight loss and T2DM management, its effects on lean body mass, physical function, and biomarkers of aging are understudied in older adults. This study aims to compare the effects of lifestyle counseling with and that without semaglutide on body composition, physical function, and biomarkers of aging in older adults. This is an open-label randomized controlled trial. A total of 20 adults (aged 65 years and older) with elevated BMI (27-40 kg/m The study was funded in December 2021 with a projected data collection period from spring 2023 through summer 2024. Despite the elevated risk of adverse changes in body composition, physical function, and biomarkers of aging among older adults with glucose intolerance and elevated adiposity, the benefits and risks of commonly prescribed antihyperglycemic or weight loss medications such as semaglutide are understudied. This study aims to fill this knowledge gap to inform clinicians about the potential for additional clinically meaningful, nonglycemic effects of semaglutide. ClinicalTrials.gov NCT05786521; https://clinicaltrials.gov/study/NCT05786521. DERR1-10.2196/62667.
Sections du résumé
BACKGROUND
BACKGROUND
Older adults with type 2 diabetes mellitus (T2DM) or prediabetes are at increased risk of adverse changes in body composition, physical function, and aging-related biomarkers compared to those with normal glucose tolerance. Semaglutide is a glucagon-like peptide 1 receptor agonist that has been approved for T2DM and chronic weight management. Although semaglutide is effective for weight loss and T2DM management, its effects on lean body mass, physical function, and biomarkers of aging are understudied in older adults.
OBJECTIVE
OBJECTIVE
This study aims to compare the effects of lifestyle counseling with and that without semaglutide on body composition, physical function, and biomarkers of aging in older adults.
METHODS
METHODS
This is an open-label randomized controlled trial. A total of 20 adults (aged 65 years and older) with elevated BMI (27-40 kg/m
RESULTS
RESULTS
The study was funded in December 2021 with a projected data collection period from spring 2023 through summer 2024.
CONCLUSIONS
CONCLUSIONS
Despite the elevated risk of adverse changes in body composition, physical function, and biomarkers of aging among older adults with glucose intolerance and elevated adiposity, the benefits and risks of commonly prescribed antihyperglycemic or weight loss medications such as semaglutide are understudied. This study aims to fill this knowledge gap to inform clinicians about the potential for additional clinically meaningful, nonglycemic effects of semaglutide.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05786521; https://clinicaltrials.gov/study/NCT05786521.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/62667.
Identifiants
pubmed: 39269759
pii: v13i1e62667
doi: 10.2196/62667
doi:
Substances chimiques
semaglutide
53AXN4NNHX
Glucagon-Like Peptides
62340-29-8
Biomarkers
0
Hypoglycemic Agents
0
Banques de données
ClinicalTrials.gov
['NCT05786521']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e62667Informations de copyright
©Tiffany M Cortes, Libia Vasquez, Monica C Serra, Ronna Robbins, Allison Stepanenko, Kevin Brown, Hannah Barrus, Annalisa Campos, Sara E Espinoza, Nicolas Musi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2024.