Table 9.
TANTALUS® studies significant outcomes
| Weight, kg |
Average Weight loss, kg (%) |
HbA1c (%) |
Average HbA1c reduction, % (% change) |
Other statistically significant or important negative results3 | |||||
| Baseline | At 3 mo ± 2 wk | At 6 mo ± 2 wk | At 12 mo ± 3 mo | Baseline | At 3 mo ± 2 wk | At 6 mo ± 2 wk | At 12 mo ± 3 mo | ||
| T1[38] | 110.5 ± 3.5 | -5.38 (-4.87%), P < 0.01 | 8.3% ± 0.12% | -1.0 (-12.0%), P < 0.001 | Lower BP (S/D) | ||||
| T2[70] | 107.7 ± 21.1 (n = 11) | -3.00 (-2.79%), P < 0.05 | -5.30 (-4.92%), P < 0.05 | 8.5% ± 0.7% | -1.0 (-11.8%), P < 0.05 | -0.9 (-10.6%), P < 0.05 | Lower BP (S) Lower total cholesterol Lower LDL | ||
| T3[39] | 123.7 ± 4.5 | -5.80 (-4.70%), P < 0.05 at 5 mo | -4.50 (-3.70%) [P < 0.05] | 8.0% ± 0.2% | -0.6 (-7.5%), P < 0.05 at 5 mo | -0.5 (-6.3%), P < 0.05 | Lower FBG Lower ghrelin4 Higher adiponectin4 Reduced appetite2 (P < 0.05) | ||
| T4[37] | NR | -5.50 (P < 0.01) | 8.4% ± 0.1% | -1.1 (-12.1%), P < 0.01 | Lower BP if hypertensive at baseline | ||||
| T5[71] | 104.4 ± 4.4 | -4.70 (-4.52%), P < 0.001 | 8.0% ± 0.2% | -1.1 (-12.8%), P < 0.001 | Lower BP (S/D) Lower FBG | ||||
| T6[69] | 130 ± 6.5 | -4.70 (-3.62%) (P value NR) at 37 wk | 8.2% ± 0.2% | -1.0 (-12.2%) (P value NR) at 37 wk | |||||
| T7[43] | NR | Increased GE Reduced gastric retention (No significant changes in Ghrelin) | |||||||
| T8[72] | 128.8 ± 5.2 | -8.90 (-6.91%), P < 0.05 at 5 mo | -16.4 (-12.7%) (P value NR)1 | Lower BP if hypertensive at baseline Reduced appetite (P < 0.05) | |||||
1
Only 9 out of 12 subjects remained by the 12th month;
2
Except from week 20 to week 52, there was a slight increase (P = NS) in hunger score, but otherwise, all scores were significant (P < 0.05);
3
Significant results in reference to baseline values;
4
Results based on a smaller subset of participants. BP: Blood pressure; LDL: Low-density lipoproteins; FBG: Fasting blood glucose.