No evidence of compensatory changes in energy balance, despite reductions in body weight and liver fat, during dapagliflozin treatment in type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled, cross-over trial (ENERGIZE).

Autor: Rajeev SP; Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, University Hospital Aintree, Liverpool, UK., Roberts CA; Department of Psychology, Institute of Population Health, University of Liverpool, Liverpool, UK., Brown E; Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, University Hospital Aintree, Liverpool, UK., Sprung VS; Liverpool University Hospitals NHS Foundation Trust, University Hospital Aintree, Liverpool, UK.; Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK., Harrold JA; Department of Psychology, Institute of Population Health, University of Liverpool, Liverpool, UK., Halford JCG; School of Psychology, University of Leeds, Leeds, UK., Stancak A; Department of Psychology, Institute of Population Health, University of Liverpool, Liverpool, UK., Boyland EJ; Department of Psychology, Institute of Population Health, University of Liverpool, Liverpool, UK., Kemp GJ; Department of Musculoskeletal and Ageing Science, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK., Perry J; Liverpool Clinical Trials Centre (LCTC), University of Liverpool, Liverpool, UK., Howarth E; Liverpool Clinical Trials Centre (LCTC), University of Liverpool, Liverpool, UK., Jackson R; Liverpool Clinical Trials Centre (LCTC), University of Liverpool, Liverpool, UK., Wiemken A; Division of Sleep Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA., Schwab R; Division of Sleep Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA., Cuthbertson DJ; Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, University Hospital Aintree, Liverpool, UK., Wilding JPH; Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; Liverpool University Hospitals NHS Foundation Trust, University Hospital Aintree, Liverpool, UK.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2023 Dec; Vol. 25 (12), pp. 3621-3631. Date of Electronic Publication: 2023 Sep 05.
DOI: 10.1111/dom.15257
Abstrakt: Aim: This study assessed the impact of dapagliflozin on food intake, eating behaviour, energy expenditure, magnetic resonance imaging (MRI)-determined brain response to food cues and body composition in patients with type 2 diabetes mellitus (T2D).
Materials and Methods: Patients were given dapagliflozin 10 mg once daily in a randomized, double-blind, placebo-controlled trial with short-term (1 week) and long-term (12 weeks) cross-over periods. The primary outcome was the difference in test meal food intake between long-term dapagliflozin and placebo treatment. Secondary outcomes included short-term differences in test meal food intake, short- and long-term differences in appetite and eating rate, energy expenditure and functional MRI brain activity in relation to food images. We determined differences in glycated haemoglobin, weight, liver fat (by 1 H magnetic resonance spectroscopy) and subcutaneous/visceral adipose tissue volumes (by MRI).
Results: In total, 52 patients (43% were women) were randomized; with the analysis of 49 patients: median age 58 years, weight 99.1 kg, body mass index 35 kg/m 2 , glycated haemoglobin 49 mmol/mol. Dapagliflozin reduced glycated haemoglobin by 9.7 mmol/mol [95% confidence interval (CI) 3.91-16.27, p = .004], and body weight (-2.84 vs. -0.87 kg) versus placebo. There was no short- or long-term difference in test meal food intake between dapagliflozin and placebo [mean difference 5.7 g (95% CI -127.9 to 139.3, p = .933); 15.8 g (95% CI -147.7 to 116.1, p = .813), respectively] nor in the rate of eating, energy expenditure, appetite, or brain responses to food cues. Liver fat (median reduction -4.7 vs. 1.95%), but not subcutaneous/visceral adipose tissue, decreased significantly with 12 weeks of dapagliflozin.
Conclusions: The reduction in body weight and liver fat with dapagliflozin was not associated with compensatory adaptations in food intake or energy expenditure.
(© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE