Table 2.
Secondary outcomes by group allocation, of participants assigned to the DIAMOND programme (n = 21) or usual care (n = 12)
| Outcome measure | Intervention group change, baseline to 12 weeks (mean ± SD) | Control group change, baseline to 12 weeks (mean ± SD) | Adjusted between group difference (mean difference, 95% CI) | P |
|---|---|---|---|---|
| Weight | ||||
| Weight, kg | −9.5 (5.4) | −2.0 (2.5) | −7.5 (−11.0 to −4.0) | <0.001* |
| Glycaemic control | ||||
| HbA1c, mmol/mol | −16.3 (13.3) | −0.7 (4.5) | −15.7 (−24.1 to −7.3) | 0.001* |
| Fasting glucose, mmol/L | −1.80 (3.0) | 0.40 (0.9) | −2.3 (−4.1 to −0.4) | 0.020* |
| Fasting insulin, pmol/L | −22.2 (25.6) | 6.60 (21.2) | −28.9 (−48.2 to −9.6) | 0.005* |
| HOMA | ||||
| HOMA‐%B | 5.6 (29.8) | −1.4 (11) | 7.3 (−12.1 to 26.6) | 0.449 |
| HOMA‐%S | 26.0 (29.8) | −2.7 (16.8) | 28.9 (8.5 to 49.5) | 0.007* |
| HOMA‐IR | −0.6 (0.6) | 0.1 (0.4) | −0.8 (−1.2 to −0.4) | 0.001* |
| Blood pressure | ||||
| Systolic blood pressure, mmHg | −9.6 (16.2) | 4.8 (10.6) | −14.4 (−25.8 to −3.0) | 0.010* |
| Diastolic blood pressure, mmHg | −5.3 (11.0) | 0.5 (8.8) | −6.0 (−13.7 to 1.8) | 0.130 |
| Lipid profile | ||||
| Total cholesterol, mmol/L | 0.05 (0.6) | 0.03 (0.4) | 0.02 (−0.4 to 0.5) | 0.900 |
| HDL, mmol/L | 0.06 (0.2) | −0.04 (0.2) | 0.09 (−0.04 to 0.22) | 0.160 |
| Triglycerides, mmol/L | −0.49 (0.7) | 0.09 (0.6) | −0.58 (−1.09 to −0.06) | 0.030* |
| Non‐HDL cholesterol, mmol/L | 0.08 (0.5) | 0.03 (0.2) | 0.06 (−0.25 to 0.37) | 0.700 |
| Total cholesterol: HDL ratio | −0.17 (0.7) | 0.10 (0.3) | −0.26 (−0.70 to 0.17) | 0.230 |
| Liver function tests | ||||
| Bilirubin, μmol/L | −1.4 (4.0) | −0.7 (2.6) | −0.7 (−3.5 to 2.2) | 0.635 |
| AST, IU/L | −5.6 (7.7) | −2.2 (6.8) | −3.0 (−8.9 to 2.8) | 0.296 |
| ALT, IU/L | −12.8 (16.0) | −3.5 (10.7) | −9.1 (−20.6 to 2.3) | 0.114 |
| ALP, IU/L | −1.5 (10.8) | −3.3 (8.1) | 1.9 (−6.3 to 10.0) | 0.470 |
| Albumin, g/L | 0.4 (3.0) | −0.5 (1.1) | 0.9 (−1.2 to 2.9) | 0.379 |
| GGT, IU/L | −17.2 (17.1) | −22.6 (81.8) | 5.8 (−34.7 to 46.3) | 0.771 |
| AST:ALT ratio | 0.1 (0.3) | 0.1 (0.3) | 0.03 (−0.19 to 0.25) | 0.764 |
| QRISK, % † | −2.6 (3.9) | 1.0 (1.8) | −3.6 (−6.2 to −1.0) | 0.008* |
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma‐glutamyl transferase; HDL, high density lipoprotein; HOMA, homeostatic model assessment; HOMA‐IR, insulin resistance; HOMA‐β, steady state β cell function; HOMA‐S, insulin sensitivity; QRISK, calculated 10‐year risk of cardiovascular disease.
*
P < 0.05.
†
exploratory outcome measure.