Clinical Study

Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes

Table 2

Characteristics of participants by different age groups at randomization.

<40 years old40–49 y50–59 y≥60 y

Total
N237 (12)462 (234)802 (41)444 (23)
Sex
 Male138 (58)238 (52)272 (34)176 (40)
Occupation
 Professional/business185 (80)330 (73)313 (40)46 (11)
 Workers17 (7)35 (8)46 (6)14 (3)
 Retired0 (0)37 (8)367 (47)354 (82)
 Jobless/others30 (13)48 (11)62 (8)19 (4)
Ethnicity
 Han226 (96)446 (97)775 (97)414 (94)
 Others9 (4)16 (4)22 (3)25 (6)
Education level
 Low1 (0)12 (3)37 (5)38 (9)
 Middle63 (27)194 (43)454 (58)206 (48)
 High170 (73)250 (55)299 (38)185 (43)
Smoking state
 Smoker (current or past)76 (32)143 (31)145 (18)72 (16)
Body shape
 BMI (kg/m2)27 (25, 30)26 (24, 28)26 (24, 28)25 (24, 28)
 Normal: BMI < 2573 (31)164 (36)316 (39)192 (43)
 Overweight: 25 ≤ BMI < 30111 (47)246 (53)398 (50)204 (46)
 Obese: BMI ≥ 3053 (22)52 (11)88 (11)48 (11)
 Waist (cm)90 (84, 98)90 (83, 96)88 (82, 94)88 (83, 95)
Blood pressure
 Systolic blood pressure (mmHg)118 (110, 123)120 (110, 126)120 (112, 130)125 (119, 133)
 Diastolic blood pressure (mmHg)76 (70, 80)78 (70, 81)79 (70, 81)78 (70, 80)
Glucose level
 Fasting plasma glucose (mmol/L)5.9 (5.3, 6.3)6.0 (5.4, 6.4)6.0 (5.5, 6.4)6.0 (5.5, 6.3)
 2 h plasma glucose (mmol/L)8.7 (7.9, 9.6)8.8 (8.0, 9.7)9.0 (8.1, 9.9)9.0 (8.3, 10.0)
 HbA1c (%)5.7 (5.4, 5.9)5.7 (5.5, 6.0)5.8 (5.6, 6.1)5.8 (5.6, 6.1)
 HbA1c (mmol/mol)39 (36, 41)39 (37, 42)40 (38, 43)40 (38, 43)
 HbA1c < 5.7% (39 mmol/mol)114 (48)180 (39)237 (30)127 (29)
 5.7% (39 mmol/mol) ≤ HbA1c < 6.5% (48 mmol/mol)112 (47)248 (54)507 (63)277 (62)
HbA1c ≥ 6.5% (48 mmol/mol)11 (5)34 (7)58 (7)40 (9)
 IGT198 (84)379 (82)680 (85)397 (89)
  Isolated IGT142 (60)253 (55)425 (53)237 (53)
  IFG + IGT56 (24)126 (27)255 (32)160 (36)
 Isolated IFG39 (17)83 (18)122 (15)47 (11)
Lipid level
 Total cholesterol (mmol/L)4.6 (4.0, 5.2)4.8 (4.2, 5.3)5.0 (4.3, 5.7)4.9 (4.3, 5.5)
 LDL-C (mmol/L)2.9 (2.5, 3.4)3.1 (2.6, 3.6)3.3 (2.7, 3.8)3.2 (2.7, 3.7)
 HDL-C (mmol/L)1.1 (1.0, 1.3)1.2 (1.0, 1.3)1.2 (1.0, 1.4)1.3 (1.1, 1.5)
 Triglyceride (mmol/L)1.7 (1.2, 2.5)1.5 (1.1, 2.1)1.5 (1.1, 2.1)1.4 (1.1, 1.9)
Liver function
 ALT (U/L)26 (18, 43)22 (16, 32)21 (16, 29)18 (14, 24)
 AST (U/L)22 (18, 28)20 (17, 26)22 (18, 26)21 (18, 25)
Hemoglobin
 Hemoglobin (g/L)148 (135, 161)146 (134, 157)140 (133, 150)140 (131, 148)
HOMA
 HOMA-IR3.2 (1.8, 4.2)2.5 (1.5, 3.4)2.4 (1.7, 3.5)2.3 (1.5, 3.3)
 HOMA-beta103.8 (66.0, 157.1)80.1 (51.9, 115.8)75.4 (51.5, 109.9)73.4 (48.7, 104.1)
Cytokines
 CRP (μmol/L)1.1 (0.6, 2.3)1.1 (0.7, 2.4)1.2 (0.7, 2.4)1.3 (0.7, 2.4)
 Adiponectin5.2 (3.7, 7.0)5.6 (3.7, 8.2)6.3 (4.6, 9.3)6.9 (4.7, 9.5)
 SOD6.5 (3.7, 9.7)7.0 (4.3, 10.4)6.9 (4.1, 10.8)6.7 (4.5, 10.0)
 Amylin7.7 (6.6, 9.4)7.6 (6.5, 9.5)7.5 (6.4, 9.3)7.5 (6.3, 9.7)
 IL-62.2 (1.5, 4.2)2.0 (1.5, 3.4)2.4 (1.5, 4.1)2.5 (1.6, 4.3)
Urine ACR
 Urine albumin/Cr (mg/g)6.4 (4.1, 13.5)7.4 (4.3, 14.3)7.4 (4.5, 14.5)7.7 (4.8, 16.9)
Diet
 Daily calories intake (kcal/d)1619 (1259, 2032)1557 (1230, 1946)1512 (1254, 1841)1515 (1244, 1893)
 Proportion of total calories intake from carbohydrate (%)58 (50, 66)59 (49, 68)59 (50, 68)61 (53, 68)
 Proportion of total calories intake from protein (%)14 (12, 17)15 (12, 17)14 (12, 17)14 (12, 16)
 Proportion of total calories intake from fat (%)25 (19, 31)24 (17, 31)24 (18, 30)23 (16, 29)
Physical activity
 Low level95 (42)133 (30)168 (22)60 (14)
 Medium level108 (47)241 (54)411 (53)224 (53)
 High level25 (11)75 (17)195 (25)141 (33)

Note. Estimates for continuous study parameters are presented by median (IQR), unless otherwise stated. Categorical study parameters are presented by number (percentage).