Characteristics | Intervention (n=45) | Control (n=45) |
Age at randomization, median (IQR) | 58.5 (50.1–64.2) | 56.1 (51.0–64.5) |
Sex, n (%) | ||
Male | 20 (44.4) | 19 (42.2) |
Female | 25 (55.6) | 26 (57.8) |
Ethnicity, n (%) | ||
Caucasian | 26 (57.8) | 27 (60.0) |
Mixed | 1 (2.2) | 1 (2.2) |
Asian | 4 (8.9) | 7 (15.6) |
Black | 14 (1.1) | 10 (22.2) |
Weight (kg), mean (SD) | 104.0 (20.2) | 103.1 (18.9) |
Body mass index (kg/m²), mean (SD) | 36.6 (5.1) | 36.8 (5.3) |
Waist circumference (cm), mean (SD) | 120.3 (12.7) | 121.5 (12.4) |
Hip circumference (cm), mean (SD) | 120.7 (12.1) | 122.0 (13.2) |
Waist-to-hip ratio, mean (SD) | 1.00 (0.06) | 1.00 (0.06) |
Body fat (%), mean (SD) | 40.4 (8.0) | 40.4 (7.4) |
HbA1c (%), mean (SD) | 8.7 (1.7) | 9.3 (1.7) |
Duration of diabetes, median (IQR) | 13.0 (9.0–20.0) | 12.0 (6.0–18.0) |
HbA1c (mmol/mol) | 72.2 (19.0) | 78.4 (18.7) |
Fasting glucose (mmol/L) | 10.10 (3.76) | 10.61 (3.02) |
Insulin (U), median (IQR) | 73.1 (41.3) | 79.4 (70) |
Insulin (U/kg), median (IQR) | 0.72 (0.42) | 0.75 (0.51) |
Duration of insulin, median (IQR) | 4.0 (2.0 to 6.2) | 4 (2.5 to 8.0) |
Other medications, n (%) | ||
Metformin | 37 (82.2) | 42 (93.3) |
SU | 10 (22.2) | 16 (35.6) |
GLP-1 | 14 (31.1) | 3 (6.7) |
Dipeptidyl peptidase IV inhibitors | 5 (11.1) | 7 (15.6) |
SGLT-2 inhibitors | 7 (15.6) | 4 (8.9) |
Thiazolidinediones | 0 (0) | 1 (2.2) |
Oral antidiabetic medications, n | 2.62 (0.94) | 2.6 (0.83) |
Blood pressure (mm Hg), mean (SD) | ||
Systolic | 131.5 (16.1) | 132.2 (17.6) |
Diastolic | 73.2 (9.1) | 74.0 (12.7) |
HDL cholesterol (mmol/L) | 1.09 (0.30) | 1.14 (0.35) |
Triglycerides (mmol/L) | 2.01 (2.14) | 1.78 (1.41) |
Hypertension, n (%) | 32 (80.0) | 35 (77.8) |
CHD, n (%) | 9 (22.5) | 12 (26.7) |
Smoking, n (%) | 8 (17.8) | 7 (15.6) |
Statins, n (%) | 40 (88.9) | 41 (91.1) |
Retinopathy, n (%) | 19 (42.2) | 16 (35.6) |
Nephropathy, n (%) | 6 (13.3) | 12 (26.7) |
Neuropathy, n (%) | 10 (25.0) | 17 (40.0) |
Estimated glomerular filtration rate (mL/min/1.73 m2) | 75.4 (17.1) | 76.9 (21.4) |
Quality of life (mm) | 68.1 (19.9) | 62.7 (19.4) |
Data presented as mean (SD), n (%) or median (IQR) unless otherwise specified.
No significant difference between groups in any characteristics.
Nephropathy defined as having estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2.
CHD, Coronary Heart Disease; GLP-1, glucagon-like peptide-1 agonist; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; SGLT-2, sodium-glucose cotransporter-2 inhibitor; SU, sulfonylurea.