Rajeev, SP, Roberts, CA, Brown, E, Sprung, VS, Harrold, JA, Halford, JCG, Stancak, A, Boyland, EJ, Kemp, GJ, Perry, J, Howarth, E, Jackson, R, Wiemken, A, Schwab, R, Cuthbertson, DJ and Wilding, JPH (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 randomised, double-blind, placebo-controlled, cross-over trial (ENERGIZE). Diabetes, Obesity and Metabolism. ISSN 1462-8902

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Abstract

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 1H 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/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. Conclusions 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:	SGLT2 inhibitor; appetite control; clinical trial; dapagliflozin; energy regulation; 1103 Clinical Sciences; Endocrinology & Metabolism
Subjects:	B Philosophy. Psychology. Religion > BF Psychology T Technology > TX Home economics > TX341 Nutrition. Foods and food supply R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RC Internal medicine > RC1200 Sports Medicine R Medicine > RM Therapeutics. Pharmacology
Divisions:	Sport & Exercise Sciences
Publisher:	Wiley
SWORD Depositor:	A Symplectic
Date Deposited:	12 Sep 2023 10:17
Last Modified:	12 Sep 2023 10:18
DOI or ID number:	10.1111/dom.15257
URI:	https://researchonline.ljmu.ac.uk/id/eprint/21417

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