SGLT-2 Inhibitor Empagliflozin Effects on Appetite and Weight Regulation: A Randomised Double-blind Placebo-controlled Trial (The SEESAW Study)
Abstract
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™).
Conditions: Diabetes Mellitus, Type 2.
Primary outcome: Change from baseline in Total PYY at 24 weeks.
Enrollment: 68 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 68 participants or records.
Read the paper
Related studies
- Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol
- Glucoraphanin: a broccoli sprout extract that ameliorates obesity-induced inflammation and insulin resistance
- SGLT2 Inhibitors in Heart Failure: Targeted Metabolomics and Energetic Metabolism
- Mechanisms of blood pressure reduction with sodium-glucose co-transporter 2 (SGLT2) inhibitors
- Sodium-glucose cotransporter inhibitors: beyond glycaemic control
- Decoding the effects of SGLT2 inhibitors on cardiac arrhythmias in heart failure
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.