Table 3.
Observational study of change in outcome variables between start and end of TDR and in all participants (combined iTDR & dTDR) (n = 23, ITT analysis).
| Factor | Change | Lower 95% CI | Upper 95% CI | p-value |
|---|---|---|---|---|
| Weight (Kg) | −6.8 | −9.5 | −4.0 | <0.001 |
| Weight (%) | −7.6 | −10.4 | −4.8 | <0.001 |
| Weight change category n (%) | <0.001 | |||
| <5% weight loss | 9 (39%) | 19% | 59% | |
| 5–9.9% weight loss | 6 (26%) | 8% | 44% | |
| >10% weight loss | 8 (35%) | 15% | 54% | |
| Remission n (%) | 10 (43%) | 23% | 64% | <0.001 |
| HbA1c (mmol/mol) | −7.2 | −12.4 | −2.0 | 0.009 |
| Net change in taking antidiabetic medication | −6 (−26%) | −52% | 0% | 0.07 |
| Net change in taking antihypertensive medication | +1 (+4%) | −15% | +23% | 0.99 |
| Waist circumference (cm) | −5.3 | −7.9 | −2.7 | <0.001 |
| SBP (mmHg) | −5.3 | −12.3 | 1.8 | 0.14 |
| Glucose (mmol/L) | −1.2 | −2.0 | −0.3 | 0.008 |
| Total cholesterol (mmol/L) | −0.3 | −0.7 | 0.2 | 0.24 |
| HDL-cholesterol (mmol/L) | −0.1 | −0.1 | 0.0 | 0.30 |
| Triglycerides (mmol/L) | −0.1 | −0.6 | 0.4 | 0.65 |
| Urea (mmol/L) | 0.1 | −0.4 | 0.6 | 0.65 |
| Uric acid (mg/dL) | 0.2 | −0.3 | 0.6 | 0.45 |
| Estimated glomerular filtration rate (ml/min/1.73 m2) | −0.4 | −4.8 | 3.9 | 0.83 |
| GGT (U/L) | −10.3 | −22.5 | 1.8 | 0.09 |
| ALT (U/L) | −3.4 | −8.3 | 1.4 | 0.16 |
| AST (U/L) | −0.2 | −3.2 | 2.8 | 0.88 |
| C-reactive protein (mg/L) | −2.0 | −3.9 | −0.1 | 0.04 |
| Ferritin (ug/L) | 2.0 | −10.4 | 14.3 | 0.75 |
| Insulin (uU/ml) | −6.4 | −11.9 | −0.9 | 0.02 |
| HOMA-IR | −2.8 | −4.8 | −0.8 | 0.007 |
| Total adipose tissue volume (L) | −3.9 | −5.5 | −2.2 | <0.001 |
| Abdominal subcutaneous adipose tissue (L) | −1.4 | −2.1 | −0.7 | <0.001 |
| Lean volume (L) | −0.5 | −0.9 | −0.1 | 0.029 |
| Liver fat (%) | −6.7 | −9.8 | −3.7 | <0.001 |
| Visceral adipose tissue volume (L) | −1.0 | −1.3 | −0.6 | <0.001 |
| EQ5D (VAS units) | 11.2 | 1.9 | 20.5 | 0.02 |