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)


Rajeev, Surya, Roberts, Carl ORCID: 0000-0003-4275-601X, Brown, Emily, Sprung, Victoria ORCID: 0000-0002-2666-4986, Harrold, Jo ORCID: 0000-0002-0899-4586, Halford, Jason ORCID: 0000-0003-1629-3189, Stancak, Andrej ORCID: 0000-0003-3323-3305, Boyland, Emma ORCID: 0000-0001-8384-4994, Kemp, Graham ORCID: 0000-0002-8324-9666, Perry, Julie et al (show 4 more authors) (2023) 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). Diabetes, Obesity and Metabolism: a journal of pharmacology and therapeutics, 25 (12). pp. 3621-3631.

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Abstract

<h4>Aim</h4>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).<h4>Materials and methods</h4>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 <sup>1</sup> H magnetic resonance spectroscopy) and subcutaneous/visceral adipose tissue volumes (by MRI).<h4>Results</h4>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<sup>2</sup> , 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.<h4>Conclusions</h4>The reduction in body weight and liver fat with dapagliflozin was not associated with compensatory adaptations in food intake or energy expenditure.

Item Type: Article
Uncontrolled Keywords: dapagliflozin, clinical trial, appetite control, SGLT2 inhibitor, energy regulation
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 05 Sep 2023 14:24
Last Modified: 13 Nov 2023 12:25
DOI: 10.1111/dom.15257
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3172546
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