. 2023 Mar 28;12(4):e220334. doi: 10.1530/EC-22-0334
This work is licensed under a Table 2.
Intervention effect on glucometabolic measures, FibroScan® measurements, parameters from MRI, anthropometric measurements, heart rate and blood pressure and biochemical parameters.
| Baseline outcome estimate (95% CI)a | Δ treatment A prednisolon placebo/curcumin placebo, estimate (95% CI)b | Δ treatment B prednisolone/curcumin placebo, estimate (95% CI)b | Δ treatment C prednisolone/curcumin, estimate (95% CI)b | ETD (B vs A), estimate (95% CI)c | P value (B vs A) | ETD (C vs A) estimate (95% CI)c | P value (C vs A) | ETD (C vs B) estimate (95% CI)c | P value (C vs B) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Glucometabolic parameters | ||||||||||
| OGIS | 415 (393; 438) | 3.0 (26; 32) | 3.2 (−25.2; 31.8) | −13.9 (−42.3; 14.6) | 0 (−38; 39) | 0.988 | −17 (−55;22) | 0.382 | −17 (−56; 21) | 0.374 |
| Insulinogenic index (pmol/mmol, %) | 39.7 (32.5; 48.5) | −18.9 (−32.1; −3.1) | 7.7 (−9.8; 28.7) | 31.3 (9.9; 56.9) | 32.7 (3.3; 70.6) | 0.028 | 61.9 (25.9; 108.0) | 0.0004 | 21.9 (−5.2; 56.7) | 0.118 |
| Disposition index (-, %) | 16319 (13695; 19447) | −17 (−32; 0.2) | 9 (−10; 33) | 26 (4; 53) | 32 (0.4; 74) | 0.046 | 52 (16; 101) | 0.003 | 15 (−12; 52) | 0.297 |
| HbA1c (mmol/mol)d | 33.3 (31.9; 34.6) | −0.8 (−1.6; 0.0) | 0.9 (0.0; 1.7) | 1.0 (0.1; 1.8) | 1.7 (0.5; 2.8) | 0.005 | 1.8 (0.6; 2.9) | 0.003 | 0.1 (−1.0; 1.2) | 0.860 |
| Glucose | ||||||||||
| Fasting (mmol/L)d | 5.2 (5.0; 4.3) | 0.2 (−0.2; 0.5) | −0.2 (−0.5; 0.2) | −0.1 (−0.4; 0.2) | −0.3 (−0.8; 0.2) | 0.207 | −0.3 (−0.7; 0.2) | 0.282 | 0.0 (−0.4; 0.5) | 0.848 |
| AUC (minutes × mmol/L) | 1481 (1421; 1541) | 24 (−64; 112) | 6 (−82; 94) | 39 (−50; 127) | −18 (−142; 106) | 0.769 | 15 (−109; 139) | 0.812 | 33 (−91; 157) | 0.595 |
| iAUC (minutes × mmol/L) | 240 (188; 291) | −13 (104; 78) | 55 (−36; 146) | 54 (−37; 145) | 68 (−60; 196) | 0.293 | 67 (−61; 195) | 0.299 | 1 (−129; 127) | 0.989 |
| Insulin | ||||||||||
| Fasting (pmol/L, %)d | 55 (45; 67) | −6 (−23; 15) | 5 (−14; 27) | 24 (2; 51) | 11 (−15; 45) | 0.428 | 32 (1; 73) | 0.044 | 19 (−9; 55) | 0.207 |
| AUC (minutes × nmol/L, %) | 58.5 (47.3; 72.0) | −18 (−31; −2) | 8 (−9; 28) | 34 (13; 50) | 31 (3; 67) | 0.028 | 64 (29; 108) | 0.0002 | 25 (−2; 58) | 0.073 |
| iAUC (minutes × nmol/L, %) | 44.6 (35.7; 55.7) | −21 (−34; −5) | 10 (−8; 32) | 36 (13; 63) | 39 (8; 80) | 0.014 | 72 (33;122) | 0.0001 | 24 (−5; 60) | 0.106 |
| C-peptide | ||||||||||
| Fasting (pmol L, %)d | 459 (390; 539) | −7 (−20; 7) | 31 (14; 52) | 45 (23; 68) | 41 (17; 71) | 0.0006 | 56 (29; 89) | < 0.0001 | 10 (−9; 33) | 0.299 |
| AUC (minutes × nmol/L, %) | 327.8 (285.3; 376.5) | −11 (−19; −2) | 20 (9; 32) | 39 (27; 54) | 35 (18; 54) | < 0.0001 | 57 (37; 79) | < 0.0001 | 16 (2; 33) | 0.029 |
| iAUC (minutes × nmol/L, %) | 213.9 (187.9; 248.8) | 13 (−21; −3) | 14 (3; 27) | 36 (22; 52) | 31 (12; 52) | 0.001 | 56 (33; 81) | < 0.0001 | 19 (2; 39) | 0.026 |
| Glucagon | ||||||||||
| Fasting (mmol / L, %)d | 20 (17; 23) | 9 (−7; 29) | 33 (13; 56) | 38 (17; 63) | 22 (−3; 53) | 0.095 | 27 (5; 29) | 0.045 | 4 (−17; 31) | 0.727 |
| AUC (minutes × mmol/L) | 3629 (3257; 4000) | −174 (−963; 615) | 970 (181; 1759) | 1090 (301; 1879) | 1144 (29; 2260) | 0.045 | 1264 (149; 2379) | 0.027 | 120 (−996; 1235) | 0.830 |
| iAUC (minutes × mmol/L) | −1401 (−1928; −875) | −767 (−1733; 199) | −930 (−1895; 36) | −1337 (−2303; −371) | −163 (−1520; 1195) | 0.810 | −570 (−1928; 788) | 0.402 | −407 (−1765; 950) | 0.549 |
| Free fatty acids | ||||||||||
| Fasting (mmol/L, %)d | 0.51 (0.42; 0.61) | −10 (−27; 12) | −9 (27; 12) | −15 (−31; 6) | 1 (−24; 33) | 0.969 | −6 (−29; 25) | 0.685 | −6 (−29; 24) | 0.657 |
| AUC (minutes × mmol/L, %) | 72 (59; 87) | −9 (−26; 13) | 12 (−10; 38) | 10 (−11; 27) | 22 (−7; 61) | 0.144 | 21 (−8; 29) | 0.169 | −1 (−25; 30) | 0.929 |
| iAUC (minutes × mmol/L) | −54 (−69; −40) | 25 (4; 47) | 25 (3; 46) | 4 (−18; 25) | −1 (−31; 29) | 0.966 | −22 (−52; 8) | 0.150 | 21 (−9; 51) | 0.162 |
| Anthropometric measurements | ||||||||||
| Body weight (kg) | 95.7 (92.0; 99.3) | 0.2 (−0.7; 1.0) | 0.3 (−0.6; 1.1) | 0.3 (−0.6; 1.2) | 0.1 (−1.1; 1.3) | 0.878 | 0.1 (−1.1; 1.4) | 0.823 | 0.0 (−1.2; 1.3) | 0.945 |
| BMI (kg/m2, %) | 29.83 (28.46; 31.27) | 0.24 (−0.69; 1.18) | 0.28 (−0.66; 0.12) | 0.29 (−0.54; 0.12) | 0.04 (−1.28; 1.37) | 0.954 | 0.06 (−1.26; 1.01) | 0.933 | 0.02 (−1.01; 1.3) | 0.979 |
| Waist circumference (cm) | 106.0 (102.1; 110.0) | 0.2 (−1.3; 1.7) | 0.6 (−0.8; 2.1) | 1.0 (−0.8; 2.7) | 0.5 (−1.6; 2.6) | 0.639 | 0.8 (−1.5; 3.0) | 0.480 | 0.3 (−1.9; 2.5) | 0.785 |
| Waist-hip-ratio | 1.04 (1.01; 1.06) | 0.01 (−0.01; 0.02) | 0.00 (−0.01; 0.02) | −0.01 (−0.03; 0.00) | −0.01 (−0.03; 0.01) | 0.508 | −0.02 (−0.04; 0.00) | 0.054 | −0.01 (−0.04; 0.01) | 0.181 |
| FibroScan® | ||||||||||
| CAP (dB) | 251 (211;291) | 14 (−20;49) | 35 (1; 70) | 2 (−36; 33) | 21 (−19; 61) | 0.292 | −16 (−56; 24) | 0.419 | −37 (−77; 3) | 0.067 |
| Liver stiffness (kPa) | 3.79 (3.38; 4.20) | 0.38 (0.35; 1.11) | 0.4 (−0.3; 1.1) | −0.02 (0.75; 0.71) | 0.00 (1.00; 1.00) | 0.997 | −0.40 (−1.40; 0.60) | 0.427 | −0.40 (−1.40; 0.60) | 0.425 |
| Magnetic resonance imaging | ||||||||||
| HFC (%) | 2.8 (1.8; 3.9) | −0.3 (−1.4; 0.8) | −0.1 (−1.2; 1.0) | 0.1 (−1.0; 1.2) | 0.2 (−1.3; 1.7) | 0.794 | 0.4 (−1.1; 1.9) | 0.578 | 0.2 (−1.3; 1.8) | 0.781 |
| SAT (cm3) | 274 (234; 313) | −1 (−8; 7) | 0.7 (−7.1; 8.4) | −4 (−12; 3) | 1 (−8; 11) | 0.780 | −4 (−13; 5) | 0.390 | −5 (−14; 4) | 0.269 |
| VAT (cm3) | 203 (151; 254) | 1 (−7; 8) | 3.9 (−4.1; 12.0) | −4 (−11; 4) | 3 (−8; 14) | 0.552 | −5 (−15; 6) | 0.380 | −8 (−19; 3) | 0.153 |
| Blood pressure and heart rate | ||||||||||
| Systolic blood pressure (mmHg) | 125 (120; 129) | −4 (−9; 1) | 2.1 (−2.9; 7.1) | 8 (3;13) | 6 (−1; 13) | 0.083 | 12 (5; 19) | 0.002 | 6 (−1; 12) | 0.117 |
| Diastolic blood pressure (mmHg) | 78 (75; 82) | −5 (−8; −2) | 1 (−1; 4) | 5 (3; 8) | 6 (3; 10) | 0.002 | 11 (7; 15) | < 0.0001 | 4 (0; 8) | 0.035 |
| Heart rate (b.p.m) | 62.4 (59.3; 65.4) | 3.5 (−1.4; 8.5) | −1.0 (−6.0; 3.9) | −6.0 (−10.9; −1.0) | −4.6 (−11.1; 1.9) | 0.157 | −9.5 (−16.0; −3.0) | 0.005 | −4.9 (−11.4; 1.6) | 0.135 |
| Biochemistry | ||||||||||
| High-density lipoprotein (mmol/L)d | 1.06 (0.99;1.13) | 0.06 (−0.05; 0.18) | 0.32 (0.21; 0.43) | 0.30 (0.18; 0.41) | 0.26 (0.10; 0.42) | 0.002 | 0.23 (0.08; 0.39) | 0.005 | −0.03 (−0.18; 0.13) | 0.726 |
| Triglyceride (mmol/L)d | 1.4 (0.9; 1.9) | −0.1 (−0.5; 0.3) | 0.1 (−0.4; 0.3) | 0.3 (−0.1; 0.6) | 0.0 (−0.4; 0.5) | 0.849 | 0.4 (−0.9; 0.8) | 0.111 | 0.3 (0.1; 0.8) | 0.159 |
| Bilirubin (µmol/L)d | 12.3 (9.3; 15.3) | 0.6 (−2.4; 3.5) | −0.3 (−3.3; 2.7) | 0.4 (−2.6; 3.3) | −0.9 (5.0; 3.3) | 0.683 | −0.2 (−4.4; 4.0) | 0.923 | 0.7 (−3.5; 4.8) | 0.755 |
| Albumin (g/L)d | 40.0 (39.1; 40.8) | 0.2 (−0.8; 1.1) | −2.8 (−3.8; −1.9) | −2.1 (−3.0; −1.2) | −3.0 (−4.3; −1.7) | < 0.0001 | −2.2 (−3.6; −0.9) | 0.001 | 0.8 (−0.6; 2.1) | 0.252 |
| Alkalic phosphatase (U/L)d | 70.9 (63.4; 78.4) | −1.5 (−5.1; 2.1) | 12.3 (−15.9; −8.7) | −8.2 (−11.8; −4.7) | −10.8 (−15.6; −6.1) | < 0.0001 | −6.8 (−11.5; −2.0) | 0.006 | 4.1 (−0.7; 8.6) | 0.092 |
| Alanine transaminase (U/L)d | 28.96 (25.61; 32.31) | 0.181 (−4.11; 4.47) | −0.92 (−5.21; 3.37) | 0.867 (−3.42; 5.16) | −1.104 (−7.17; 4.96) | 0.715 | 0.686 (−5.38; 6.75) | 0.821 | −1.79 (−7.85; 4.27) | 0.555 |
| Aspartate transaminase (U/L)d | 22.13 (19.61; 24.65) | −0.79 (−4.30; 2.71) | −7.88 (−11.39; −4.38) | −7.07 (−10.58; −3.57) | −7.09 (−11.47; −2.71) | 0.002 | −6.28 (−10.66; −1.90) | 0.006 | 0.81 (−3.57; 5.19) | 0.712 |
| LDH (U/L)d | 177 (167; 186) | −7 (−18; 5) | −8.8 (−19.6; 2.0) | −25 (−36; −13) | −2 (−17; 13) | 0.803 | −18 (−34; −2) | 0.027 | −16 (−31; −1) | 0.040 |
| GGT (U/L, %)d | 22.0 (17.8; 27.3) | −1.3 (−16.1; 15.9) | 23.8 (5.3; 45.5) | 14.5 (−2.6; 24.6) | 25.4 (0.2; 56.9) | 0.048 | 16.1 (−7.3; 45.2) | 0.188 | −7.5 (−26.1; 15.8) | 0.489 |
| Urea synthesis (mmol/minute)d | 0.342 (0.295; 0.390) | 0.007 (−0.084; 0.097) | −0.0 (−0.1; 0.1) | 0.010 (−0.084; 0.103) | −0.007 (−0.142; 0.127) | 0.912 | 0.003 (−0.126; 0.133) | 0.959 | 0.011 (−0.126; 0.148) | 0.875 |
| CRP (mg/L)d | 1.414 (1.004; 1.824) | 0.226 (−0.173; 0.624) | −0.632 (−1.031; −0.234) | −0.887 (−1.286; −0.489) | −0.858 (−1.321; −0.396) | 0.001 | −1.113 (−1.567; −0.650) | < 0.0001 | −0.255 (−0.717; 0.208) | 0.273 |
| Creatine kinase (U/L)d | 164 (126; 202) | −7 (−39; 25) | −71.8 (−102.1; −41.5) | −72 (−104; 41) | −65 (−103; −26) | 0.002 | −65 (−105; −26) | 0.002 | −1 (−39; 38) | 0.972 |
aBaseline outcome is mean for normally distributed outcomes/geometric mean for skewed outcomes. bΔ is estimated mean difference/relative difference in geometric means. cETD is baseline adjusted mean difference/relative difference in geometric means. All results are based on the constrained linear mixed model. The following outcomes were log-transformed prior to analysis due to skewness: insulinogenic index, disposition index, fasting levels of insulin, C-peptide, glucagon and free fatty acids, body mass index (BMI), gamma glutamyltransferase (GGT), area under the curve (AUC) of insulin, C-peptide, free fatty acids, incremental AUC (iAUC) of insulin and C-peptide. dConcentrations in the fasted state.
ALT, alanine transaminase; AST, aspartate transaminase; CAP, controlled attenuation parameter; CRP, C-reactive protein; ETD; estimated treatment difference; HbA1c, glycated haemoglobin A1c; HFC, hepatic fat content; HOMA2-IR, homeostatic model assessment of insulin resistance; LDH, lactate dehydrogenase; OGIS, oral glucose insulin sensitivity index; SAT, subcutaneous adipose tissue volume; VAT, visceral adipose tissue volume.