Table I.
| Table IA. Demographics and Psychological Characteristics at Baseline (mean ± SE unless otherwise noted) | |||
|---|---|---|---|
| Placebo (N=62) |
Sibutramine, 10 mg (N=58) |
Sibutramine, 15 mg (N=61) |
|
| # obese / # overweight | 51/11 | 48/10 | 50/11 |
| Age, y | 41.3 ± 1.4 | 42.2 ± 1.4 | 44.8 ± 1.3 |
| Gender (%Female) | 87% | 91% | 89% |
| Waist circumference, cm | 105.1 ± 1.6 | 102.3 ± 1.5 | 101.9 ± 1.5 |
| Weight, kg | 95.9 ± 2.1 | 95.6 ± 2.2 | 93.1 ± 2.2 |
| BMI, kg/m2 | 34.5 ± 0.6 | 34.8 ± 0.7 | 33.9 ± 0.6 |
| Fasting blood glucose, pre | 94.6 ± 1.3 | 95.6 ± 2.2 | 93.2 ± 2.1 |
| Anxiety (HAD score) | 4.4 ± 0.3 | 5.0 ± 0.4 | 4.5 ± 0.4 |
| Gastric emptying, T ½, min | 77.9 ± 2.5 | 82.1 ± 3.1 | 82.4 ± 2.5 |
| Depression (HAD score) | 3.1 ± 2.3 | 3.3 ± 0.3 | 3.0 ± 0.3 |
| SAAST score | 2.2 ± 0.2 | 2.2 ± 0.2 | 2.1 ± 0.2 |
| Hunger | 5.7 ± 0.4 | 5.4 ± 0.5 | 5.4 ± 0.4 |
| Disinhibition | 8.9 ± 0.5 | 8.8 ± 0.5 | 8.8 ± 0.4 |
| Cognitive Restraint | 9.8 ± 0.6 | 9.1 ± 0.6 | 10.6 ± 0.7 |
| % of participants performing regular physical activity | 40 | 31 | 41 |
| Table IB. Distribution of Genotypes (single and combined) by Treatment Groups | ||||
|---|---|---|---|---|
| Note that randomization was balanced on 5HTTLPR genotype. The randomization also resulted in similar distributions of single and combined genotypes, particularly for α2A and 5HTTLPR. | ||||
|
Genotypes: |
Placebo (n=62) |
Sibutramine, 10 mg (n=58) |
Sibutramine, 15 mg (n=61) |
P values§ |
| α2A | 0.62 | |||
| α2A (CC), n (%) | 36 (58) | 29 (50) | 31 (51) | |
| α2A (GC/GG), n (%) | 26 (42) | 29 (50) | 30 (49) | |
| GN β3 | 0.08 | |||
| GNβ3 (CC), n (%) | 22 (35) | 31 (53) | 32 (52) | |
| GNβ3 (TC/TT), n (%) | 40 (65) | 27 (47) | 29 (48) | |
| 5HTTLPR | 0.92 | |||
| 5HTTLPR (LL), n (%) | 20 (32) | 17 (29) | 18 (29) | |
| 5HTTLPR (LS/SS), n (%) | 42 (68) | 41 (71) | 43 (71) | |
| α2A and GN β3 | 0.25 | |||
| α2A (CC) and GN β3 (TC/TT), n(%) | 28(45) | 15(26) | 16(26) | |
| α2A (CC) and GN β3 (CC), n(%) | 8(13) | 14(24) | 15(25) | |
| α2A (CG/GG) and GN β3 (TC/TT),n(%) | 12(19) | 12(21) | 13(21) | |
| α2A (CG/GG) and GN β3 (CC),n(%) | 14(23) | 17(29) | 17(28) | |
| 5HTTLPR and GN β3 | 0.31 | |||
| 5HTTLPR (LS/SS) and GN β3 (TC/TT),n(%) | 28(45) | 17(29) | 18(30) | |
| 5HTTLPR (LS/SS) and GN β3 (CC),n(%) | 14(23) | 24(41) | 25(41) | |
| 5HTTLPR (LL) and GN β3 (TC/TT),n(%) | 12(19) | 10(17) | 11(18) | |
| 5HTTLPR (LL) and GN β3 (CC),n(%) | 8(13) | 7(12) | 7(11) | |
| α2A and 5HTTLPR | 0.41 | |||
| α2A (CC) and 5HTTLPR (LS/SS), n(%) | 21(34) | 19(38) | 24(31) | |
| α2A (CC) and 5HTTLPR (LL), n(%) | 15(24) | 10(17) | 7(11) | |
| α2A (CG/GG) and 5HTTLPR (LS/SS), n(%) | 21(34) | 22(38) | 19(31) | |
| α2A (CG/GG) and 5HTTLPR (LL), n(%) | 5(8) | 7(12) | 11(18) | |
Three-Factor Eating Questionnaire was used to measure hunger, disinhibition, cognitive restraint; SAAST score is derived from responses to self-administered alcoholism screening test, based on 35 questions. As would be expected based on the randomization, there were no significant differences in the three groups.
§
Chi-square test for association between genotype (or genotype combination) and treatment group assignment.