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)

Author:

Rajeev Surya Panicker12,Roberts Carl Alexander3ORCID,Brown Emily12,Sprung Victoria S.24,Harrold Jo A.3,Halford Jason C. G.5,Stancak Andrej3,Boyland Emma J.3,Kemp Graham J.6,Perry Julie7,Howarth Elaine7,Jackson Richard7,Wiemken Andrew8,Schwab Richard8,Cuthbertson Daniel J.12,Wilding John P. H.12

Affiliation:

1. Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences University of Liverpool Liverpool UK

2. Liverpool University Hospitals NHS Foundation Trust University Hospital Aintree Liverpool UK

3. Department of Psychology, Institute of Population Health University of Liverpool Liverpool UK

4. Research Institute for Sport and Exercise Sciences Liverpool John Moores University Liverpool UK

5. School of Psychology University of Leeds Leeds UK

6. Department of Musculoskeletal and Ageing Science, Institute of Life Course and Medical Sciences University of Liverpool Liverpool UK

7. Liverpool Clinical Trials Centre (LCTC) University of Liverpool Liverpool UK

8. Division of Sleep Medicine University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania USA

Abstract

AbstractAimThis 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 MethodsPatients 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 1H magnetic resonance spectroscopy) and subcutaneous/visceral adipose tissue volumes (by MRI).ResultsIn 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/m2, 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.ConclusionsThe reduction in body weight and liver fat with dapagliflozin was not associated with compensatory adaptations in food intake or energy expenditure.

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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