Table 1.
Demographic, clinical, laboratory characteristics and use of oral anti-diabetic medications of patients randomized to oral sodium bicarbonate (Treated) or conventional therapy (controls) at study inception
| Overall | Treated | Control | p-value | |
|---|---|---|---|---|
| (N = 145) | (N = 71) | (N = 74) | ||
| Males, N (%) | 83 (57 %) | 47 (66 %) | 36 (48 %) | NS |
| Age, years | 65.5 ± 11.4 | 64.9 ± 11.8 | 66.0 ± 12.9 | NS |
| Body Weight, kg | 75.5 ± 14.1 | 76.5 ± 14.6 | 73.4 ± 11.2 | NS |
| Cardiovascular disease, N(%) | 36 (25) | 17 (24) | 19 (26) | NS |
| Systolic blood pressure, mmHg | 122 ± 20 | 124 ± 19 | 120 ± 22 | NS |
| Disatolic blood pressure, mmHg | 73 ± 9 | 73 ± 8 | 73 ± 10 | NS |
| Serum Bicarbonate, mEql/l | 21.4 ± 1.9 | 21.2 ± 1.9 | 21.6 ± 2.0 | NS |
| Serum Gucose, mg/dl | 150 ± 44 | 149 ± 41 | 151 ± 47 | NS |
| HbA1C % | 6.76 ± 1.2 | 6.74 ± 1.0 | 6.8 ± 1.4 | NS |
| Serum creatinine,mg/dl | 2.1 ± 0.8 | 2.3 ± 0.8 | 2.0 ± 0.7 | NS |
| BUN, mg/dl | 87 ± 32 | 93 ± 35 | 81 ± 28 | NS |
| Creatinine clearance, ml/min | 33 ± 14 | 32 ± 14 | 35 ± 15 | NS |
| Uric Acid, mg/dl | 5.4 ± 1.8 | 5.6 ± 1.9 | 5.1 ± 1.8 | NS |
| Serum sodium, mEql/l | 139 ± 3 | 139 ± 3 | 139 ± 2 | NS |
| Serum potassium, mEq/l | 4.82 ± 0.7 | 4.85 ± 0.6 | 4.79 ± 0.7 | NS |
| Total serum calcium, mg/dl | 9.13 ± 0.6 | 9.14 ± 0.62 | 9.12 ± 0.58 | NS |
| Serum phosphate, mg/dl | 3.7 ± 0.7 | 3.8 ± 0.7 | 3.7 ± 0.7 | NS |
| Serum albumin, g/dl | 3.86 ± 0.42 | 3.85 ± 0.39 | 3.89 ± 0.46 | NS |
| Hemoglobin, g/dl | 12.3 ± 1.7 | 12.26 ± 1.82 | 12.39 ± 1.68 | NS |
| C-Reactive Protein, mg/l | 11.20 ± 28.1 | 11.08 ± 34.37 | 11.34 ± 18.53 | NS |
| Serum PTH, pg/ml | 122 ± 83 | 119 ± 34 | 124 ± 88 | NS |
| Serum total cholesterol, mg/dl | 154 ± 34 | 158 ± 34 | 151 ± 33 | NS |
| Serum LDL cholesterol, mg/dl | 91 ± 32 | 93 ± 31 | 87 ± 32 | NS |
| Serum HDL cholesterol, mg/dl | 45 ± 14 | 45 ± 12 | 45 ± 16 | NS |
| Serum triglicerides, mg/dl | 134 ± 58 | 130 ± 56 | 138 ± 60 | NS |
| vitamin D (25-OH.D), ng/ml | 39 ± 11 | 39 ± 10 | 38 ± 10 | NS |
| Homa-IR | 7.17 ± 2.4 | 7.13 ± 2.5 | 7.20 ± 2.36 | NS |
| HOMA % B | 49 ± 21 | 50 ± 22 | 48 ± 21 | NS |
| Serum insulin, mcIU | 18.3 ± 6.6 | 17.6 ± 6.1 | 19.0 ± 7.0 | NS |
| Antidiabetic medications | ||||
| Biguanides, number (%) | 98 (67.5) | 52 (73.2) | 46 (62.2) | NS |
| dose, mg/day | 1740 ± 417 | 1760 ± 611 | 1725 ± 670 | NS |
| Solfonylureas, number (%) | 46 (31.7) | 17 (23.9) | 29 (39.2) | NS |
| dose, mg/day | 5.25 ± 1.19 | 5.29 ± 1.38 | 5.23 ± 1.14 | NS |
| Meglitinides, number (%) | 41 (28.3) | 21 (29.6) | 20 (27) | NS |
| dose, mg/day | 3.13 ± 1.35 | 3.52 ± 0.91 | 2.76 ± 1.59 | NS |
| Use of > 1 medication, number (%) | 37 (25.5) | 20 (28.1) | 17 (23) | NS |
| Antihypertensive DRUGS | ||||
| Furosemide, number (%) | 131 (90.3) | 62 (87.3) | 69 (93.3) | NS |
| dose, mg/day | 55 ± 19 | 55 ± 21 | 55 ± 17 | NS |
| ARB inhibitors, number (%) | 75 (51.7) | 37 (23.9) | 38 (39.2) | NS |
| ACE-Inhibitors, number (%) | 74 (51) | 38 (52.1) | 36 (48.6) | NS |
| Beta-blocker (%) | 24 (16.5) | 14 (19.7) | 10 (13.5) | NS |
| Other antihypertensive drugs number (%) | 42 (28.9) | 20 (28.2) | 22 (29.7) | NS |
| Use of > 1 medication, number (%) | 70 (48.3) | 38 (53.5) | 32 (43.2) | NS |
Continuous and dichotomous variables are expressed as mean ± standard deviation or count (%), respectively