Table 2.
Change in outcome variables during the RCT (ITT analysis).
| Factor | Change in dTDR (control) | Change in iTDR (intervention) | p-value | Between group change (95% CI) |
|---|---|---|---|---|
| Number analysed | 12 | 13 | ||
| Weight (kg) | −0.9 (1.2) | −7.2 (7.8) | 0.011 | −6.3 (−11.0, −1.6) |
| Weight (%) | −1.2 (1.4) | −7.7 (7.2) | 0.005 | −6.5 (−10.9, −2.1) |
| Weight change category | ||||
| <5% weight loss | 12 (100%) | 5 (38%) | 0.004 | – |
| 5–9.9% weight loss | 0 (0%) | 2 (15%) | – | |
| >10% weight loss | 0 (0%) | 6 (46%) | – | |
| Remission | 0 (0%) | 5 (38%) | 0.039 | – |
| HbA1c (mmol/mol) | −0.7 (5.6) | −5.5 (11.0) | 0.20 | −4.7 (−12.0, 2.6) |
| Taking antidiabetic medication | 9 (75%) | 3 (23%) | 0.017 | – |
| Taking antihypertensive medication | 4 (33%) | 1 (8%) | 0.16 | – |
| Waist circumference (cm) | 0.2 (4.8) | −4.8 (5.7) | 0.027 | −5.0 (−9.3, −0.6) |
| SBP (mmHg) | −5.1 (17.4) | −3.9 (11.1) | 0.84 | 1.2 (−10.7, 13.2) |
| Glucose (mmol/L) | −0.5 (1.68) | −1.0 (1.5) | 0.41 | −0.5 (−1.9, 0.8) |
| Total cholesterol (mmol/L) | 0.0 (0.4) | −0.1 (1.1) | 0.91 | 0.0 (−0.7, 0.6) |
| HDL-cholesterol (mmol/L) | −0.03 (0.14) | −0.02 (0.18) | 0.83 | −0.0 (−0.1, 0.1) |
| Triglycerides (mmol/L) | −0.28 (0.71) | −0.03 (1.4) | 0.59 | 0.2 (−0.7, 1.2) |
| Urea (mmol/L) | 0.1 (1.1) | 0.2 (1.1) | 0.82 | 0.1 (−0.8, 1.0) |
| Uric acid (mg/dL) | −0.3 (0.6) | 0.1 (1.2) | 0.34 | 0.4 (−0.4, 1.2) |
| Estimated glomerular filtration rate (ml/min/1.73 m2) | 1.1 (5.9) | −0.5 (10.4) | 0.65 | −1.6 (−8.7, 5.5) |
| GGT (U/L) | −16 (67) | −3 (14) | 0.47 | 13 (−25, 53) |
| ALT (U/L) | −2 (7) | −2 (11) | 0.97 | 0 (−8, 8) |
| AST (U/L) | −1 (4) | 1 (7) | 0.31 | 2 (−2, 7) |
| C-reactive protein (mg/L) | −0.8 (2.2) | −2.7 (5.6) | 0.27 | −1.9 (−5.5, 1.6) |
| Ferritin (ug/L) | −8 (17) | 5 (33) | 0.25 | 12 (−10, 35) |
| Insulin (uU/ml) | −2.4 (8.1) | −7.9 (15.3) | 0.27 | −5.6 (−15.8, 4.7) |
| HOMA-IR | −1.9 (4.5) | −3.3 (5.2) | 0.48 | −1.4 (−5.4, 2.7) |
| Total adipose tissue volume (L) | −0.5 (0.7) | −4.3 (4.5) | 0.008 | −3.8 (−6.5, −1.1) |
| Abdominal subcutaneous adipose tissue (L) | −0.13 (0.45) | −1.63 (1.98) | 0.018 | −1.5 (−2.7, −0.3) |
| Lean volume (L) | 0.0 (0.4) | −0.8 (1.0) | 0.029 | −0.7 (−1.4, −0.1) |
| Liver fat (%) | −1.4 (3.1) | −7.0 (8.1) | 0.035 | −5.6 (−10.8, −0.4) |
| Visceral adipose tissue volume (L) | −0.1 (0.3) | −1.0 (0.8) | 0.001 | −0.9 (−1.4, −0.4) |
Data for within group changes are count (%) or mean (SD).