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 1

Characteristics of participants by different lifestyle intervention at randomization.

ConventionalIntensiveAll

N972 (50)973 (50)1945
Sex
 Male450 (46)374 (38)824 (42)
Age (years)
 mean ± SD52 ± 1053 ± 1053 ± 10
Occupation
 Professional/business447 (47)427 (45)874 (46)
 Workers59 (6)53 (6)112 (6)
 Retired362 (38)396 (42)758 (40)
 Jobless/other83 (9)76 (8)159 (8)
Ethnicity
 Han934 (97)927 (96)1861 (96)
 Others31 (3)41 (4)72 (4)
Education level
 Low46 (5)42 (4)88 (5)
 Middle468 (49)449 (47)917 (48)
 High436 (46)468 (49)904 (47)
Smoking state
 Current smoker or past smoker234 (24)202 (21)436 (23)
Body shape
 BMI (kg/m2)26 (24, 28)26 (24, 28)26 (24, 28)
 Normal: BMI < 25385 (40)360 (37)745 (38)
 Overweight: 25 ≤ BMI < 30464 (48)495 (51)959 (49)
 Obese: BMI ≥ 30123 (13)118 (12)241 (12)
 Waist (cm)89 (83, 96)88 (82, 95)89 (82, 95)
Blood pressure
 Systolic blood pressure (mmHg)120 (111, 130)120 (110, 130)120 (110, 130)
 Diastolic blood pressure (mmHg)79 (70, 81)77 (70, 80)78 (70, 80)
Glucose level
 Fasting plasma glucose (mmol/L)6.0 (5.5, 6.4)6.0 (5.5, 6.4)6.0 (5.5, 6.4)
 2h plasma glucose (mmol/L)8.8 (8.1, 9.8)8.9 (8.1, 9.9)8.9 (8.1, 9.9)
 HbA1c (%)5.8 (5.6, 6.0)5.8 (5.5, 6.1)5.8 (5.6, 6.1)
 HbA1c (mmol/mol)40 (38, 42)40 (37, 43)40 (38, 43)
 HbA1c < 5.7% (39 mmol/mol)331 (34)327 (34)658 (34)
 5.7% (39 mmol/mol) ≤ HbA1c < 6.5% (48 mmol/mol)572 (59)572 (59)1144 (59)
 HbA1c ≥ 6.5% (48 mmol/mol)69 (7)74 (8)143 (7)
 IGT821 (85)833 (86)1654 (85)
  Isolated IGT532 (55)525 (54)1057 (54)
  IFG + IGT289 (30)308 (32)597 (31)
 Isolated IFG151 (16)140 (14)291 (15)
Lipid level
 Total cholesterol (mmol/L)4.9 (4.3, 5.5)4.9 (4.3, 5.4)4.9 (4.3, 5.5)
 LDL-C (mmol/L)3.2 (2.7, 3.7)3.1 (2.6, 3.7)3.2 (2.6, 3.7)
 HDL-C (mmol/L)1.2 (1.0, 1.4)1.2 (1.0, 1.4)1.2 (1.0, 1.4)
 Triglyceride (mmol/L)1.5 (1.1, 2.1)1.5 (1.1, 2.0)1.5 (1.1, 2.1)
Liver function
 ALT (U/L)21 (16, 31)21 (15, 29)21 (16, 30)
 AST (U/L)22 (18, 26)21 (17, 26)21 (18, 26)
Hemoglobin
 Hemoglobin (g/L)143 (134, 153)141 (132, 152)142 (133, 153)
HOMA
 HOMA-IR2.4 (1.6, 3.5)2.4 (1.6, 3.6)2.4 (1.6, 3.5)
 HOMA-beta77. 5 (50.8, 113.1)79.9 (52.3, 116.7)78.5 (51.8, 114.7)
Cytokines
 CRP (μmol/L)1.2 (0.7, 2.3)1.2 (0.7, 2.4)1.2 (0.7, 2.4)
 Adiponectin6.2 (4.2, 8.8)6.2 (4.3, 9.0)6.2 (4.3, 8.9)
 SOD6.8 (4.1, 10.3)6.9 (4.3, 10.5)6.9 (4.2, 10.4)
 Amylin7.7 (6.5, 9.5)7.5 (6.4, 9.3)7.6 (6.4, 9.4)
 IL-62.3 (1.5, 4.2)2.3 (1.5, 3.8)2.3 (1.5, 4.0)
Urine ACR
 Urine albumin/Cr (mg/g)7.4 (4.5, 15.2)7.4 (4.4, 14.3)7.4 (4.5, 14.7)
Diet
 Daily calories intake (kcal/d)1521 (1242, 1874)1554 (1248, 1920)1535 (1243, 1899)
 Proportion of total calories intake from carbohydrate (%)60 (51, 69)59 (50, 67)60 (50, 68)
 Proportion of total calories intake from protein (%)14 (12, 16)14 (12, 17)14 (12, 17)
 Proportion of total calories intake from fat (%)23 (17, 30)24 (18, 31)24 (17, 30)
Physical activity
 Low level232 (25)224 (24)456 (24)
 Medium level483 (52)501 (53)984 (53)
 High level223 (24)213 (23)436 (23)

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