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)
Authors' conclusion
The reduction in body weight and liver fat with dapagliflozin was not associated with compensatory adaptations in food intake or energy expenditure.
Study context
- Population
- Patients with T2D; median age 58 years, weight 99.1 kg, BMI 35 kg/m², HbA1c 49 mmol/mol; 43% women49 analysed
- Participants
- 52 patients
- Comparison
- Dapagliflozin 10 mg once daily vs placebo
- Primary endpoint
- Difference in test meal food intake between long-term dapagliflozin and placebo
- Follow-up
- Long-term (12 weeks)
Methodological detailsdouble-blind, placebo-controlled, cross-over, short-term (1 week) and long-term (12 weeks) cross-over periods
- Double-blind
- Placebo-controlled
- Cross-over
- Short-term (1 week) and long-term (12 weeks) cross-over periods
Primary result
Test meal food intake
Mean difference
15.8 g
95% CI −147.7 to 116.1
P = 0.813
Between Dapagliflozin and Placebo
mean difference 15.8 g (95% CI −147.7 to 116.1); P = 0.813
As reported in the abstract
Secondary outcomes
| Outcome | Mean difference (g) (95% CI) | P value | |
|---|---|---|---|
| Test meal food intake, short-term · short-term (1 week) | 5.7 (−127.9 to 139.3) | P = 0.933 | |
| −200−1000100200Difference, g (linear scale) |
kg
| Outcome | Dapagliflozin | Placebo | Reduction (mmol/mol) (95% CI) | P value |
|---|---|---|---|---|
| HbA1cLower with dapagliflozin | 9.7 (3.91–16.27) | P = 0.004 | ||
| Body weight change | −2.84 | −0.87 |
Eating rate, energy expenditure, appetite, brain responses to food cues
- No short- or long-term difference between dapagliflozin and placebo
Liver fat · 12 weeks
- Liver fat decreased significantly with dapagliflozin (median reduction −4.7 vs. 1.95%)
Subcutaneous/visceral adipose tissue · 12 weeks
- No significant decrease with dapagliflozin
Original publication
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 Obes Metab. Published 5 September 2023. doi:10. 1111/ dom. 15257
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