Table 3.
Details of clinical trials investigating effects of Sildenafil on energy expenditure/BAT activity.
| Author | Agent | Study Design | Dose | Population | Duration | Measurement of energy expenditure | Effect on energy expenditure | Key findings |
|---|---|---|---|---|---|---|---|---|
| Li et al. (31) | Sildenafil | Randomized, double blinded, placebo controlled, parallel group trial | 100 mg/day sildenafil in fractionated dose (25 mg at 8AM plus 25mg at 4PM plus 50mg at 10PM) VS identical placebo | 16 newly diagnosed Chinese male overweight subjects, age 20-30 | 7 days | Measurement of EE not specified. | ↑ | Increase from baseline in RMR [1465 ± 196 kcal/day (pre) vs 1642 ± 166 kcal/day (post), P<0.01]. No significant changes in weight. |
| Zemel et al. (32) | NS-0200 (combination of leucine, metformin and sildenafil) |
Randomized, placebo controlled, double blinded, phase 2 multicenter study | Placebo, Low dose NS-0200 (1.1g leucine/0.5g metformin/0.5mg sildenafil) and high dose NS-0200 (1.1g leucine/0.5g metformin/1mg sildenafil) | 91 subjects, age 18-75, BMI 25-40, stable health and body weight for the preceding 12 weeks, MRI-PDFF>/= 15%, ALT>/= 30U/L for men and 19U/L for women. | 16 weeks | Measurement of EE not specified | Not specified. | NS-0200 dose responsively reduced weight by 2.4kg in the study cohort. |
EE, energy expenditure; RMR, resting metabolic rate.