SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation.
Status:
Completed
Trial end date:
2019-07-30
Target enrollment:
Participant gender:
Summary
The aim of this study is to investigate the cause for the discrepancy in predicted and
observed weight loss with Empagliflozin (Jardiance™) by measuring appetite regulation.
Major secondary objectives are to determine the effects of Empagliflozin (Jardiance™) on
energy expenditure and change in total body weight and body composition.
The primary outcome is change in appetite hormone concentrations (specifically total PYY)
between baseline and 24 weeks: - this will be measured by sequential blood sampling during
visits 1-5.
Secondary outcomes, which are exploratory, are effect on appetite hormones (ghrelin and
GLP-1), appetite perceptions, total body weight and fat and fat free mass, energy
expenditure, appetite perception, physical activity and blood and urine biochemical
parameters after Empagliflozin (Jardiance™) treatment for 24 weeks.
The sample size for the study is 76 participants and the planned trial duration is 21 months,
with participants receiving approximately 24 weeks of exposure to Empagliflozin (Jardiance™).
Phase:
Phase 4
Details
Lead Sponsor:
University of Leicester
Collaborators:
Loughborough University University Hospitals, Leicester