Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Original Article

Volume 10, Number 3, March 2018, pages 182-188


A Randomized Controlled Trial of a Mini Low-Carbohydrate Diet and an Energy-Controlled Diet Among Japanese Patients With Type 2 Diabetes

Figures

Figure 1.
Figure 1. Study design. Mini-LCD: mini low-carbohydrate diet; ECD: energy-controlled diet; Tx: therapy; OHA: oral hypoglycemic agent.
Figure 2.
Figure 2. The flow of patient selection in this study. Mini-LCD: mini low-carbohydrate diet; ECD: energy-controlled diet; ITT: intention to treat.
Figure 3.
Figure 3. Change in HbA1c (%). Mini-LCD: mini low-carbohydrate diet; ECD: energy-controlled diet; HbA1c: glycosylated hemoglobin.
Figure 4.
Figure 4. Change in body weight (kg). Mini-LCD: mini low-carbohydrate diet; ECD: energy-controlled diet.

Tables

Table 1. Baseline Characteristics Before and After Propensity Score Matching
 
Before propensity score matchingAfter propensity score matching
Mini low-carbohydrate diet groupEnergy-controlled diet groupP valueMini low-carbohydrate diet groupEnergy-controlled diet groupP value
Data are expressed as means ± standard error or median values (interquartile ranges); P values between two groups were determined using the t-test. One-to-one nearest-neighbor matching with replacement based on propensity score was performed. To test the approach and maximize the number of matching, the process was repeated without a replacement option, using calipers and logit of the propensity score. Calipers of width equal to 0.25 of the standard deviation of the logit score. BMI: body mass index; HbA1c: glycosylated hemoglobin; HDL: high-density lipoprotein; LDL: low-density lipoprotein.
Number25231212
Men/women (n)8/178/150.922/104/80.35
Age (years)64.4 ± 2.365.2 ± 2.20.8264.4 ± 3.266.0 ± 3.20.73
Diabetes duration (years)11.2 ± 1.9013.3 ± 2.00.4612.2 ± 3.28.5 ± 3.20.42
Body weight (kg)67.1 ± 2.458.2 ± 2.50.0159.2 ± 3.060.7 ± 3.00.73
BMI (kg/m2)26.6 ± 4.322.9 ± 3.50.0124.4 ± 1.123.8 ± 1.10.71
Waist circumference (cm)88.2 ± 1.781.0 ± 1.80.0184.3 ± 2.784.2 ± 2.70.99
HbA1c (%)7.0 ± 0.17.0 ± 0.10.967.0 ± 0.27.0 ± 0.20.88
HDL-cholesterol (mg/dL)60.2 ± 3.360.9 ± 3.40.8865.3 ± 6.062.3 ± 6.00.72
LDL-cholesterol (mg/dL)113.2 ± 5.4115.7 ± 5.60.75107.0 ± 6.7131.0 ± 6.70.018
Triglycerides (mg/dL)158 (122 - 194)121 (89 - 164)0.22173 (110 - 236)114 (52 - 177)0.19
Basal energy expenditure (kcal/day)1,338.7 ± 42.11,278.1 ± 44.90.341,228.0 ± 52.61,320.7 ± 52.60.23
Fat mass (%)32.3 ± 1.728.7 ± 1.80.1032.2 ± 2.629.4 ± 2.60.47
Diet treatment only/diet treatment plus oral hypoglycemic agents10/1510/130.687/55/70.70
DTSQ total score24.1 ± 2.225.5 ± 2.40.6726.3 ± 3.422.8 ± 3.70.49

 

Table 2. Treatment Time Course Before and After Propensity Score Matching
 
Before propensity score matchingAfter propensity score matching
Baseline4 weeks8 weeks12 weeksChange from the baselineP valueBaseline4 weeks8 weeks12 weeksChange from the baselineP value
Data are expressed as means ± standard error. P values between two groups were determined using the t-test. Chi-squared test was used for categorical variables, and Mann-Whitney U test for continuous non-normally distributed variables. Multiple imputations were used to adjust for age, sex, body weight, HbA1c, basal energy expenditure, waist circumference, and height. The percentages of nutrient energy per daily energy intake are also shown before and after propensity score matching. Mini-LCD: mini low-carbohydrate diet; ECD: energy-restricted diet; HbA1c: glycosylated hemoglobin; 1,5-AG: 1,5-anhydroglucitol; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; TG: triglyceride; DTSQ: Diabetes Treatment Satisfaction Questionnaire; Q2: question 2; Q3: question 3.
HbA1c (%)Mini-LCD7.0 ± 0.16.8 ± 0.16.8 ± 0.16.7 ± 0.1-0.2 ± 0.070.607.03 ± 0.166.97 ± 0.166.91 ± 0.146.85 ± 0.15-0.2 ± 0.10.95
ECD7.0 ± 0.16.9 ± 0.16.8 ± 0.16.8 ± 0.1-0.2 ± 0.077.00 ± 0.166.92 ± 0.166.85 ± 0.146.81 ± 0.15-0.2 ± 0.09
Glycated albumin (%)Mini-LCD17.7 ± 0.417.6 ± 0.4-0.1 ± 0.30.3717.9 ± 0.418.3 ± 0.50.5 ± 0.40.32
ECD18.5 ± 0.418.3 ± 0.4-0.2 ± 0.318.7 ± 0.418.6 ± 0.5-0.1 ± 0.4
1,5 AGMini-LCD10.4 ± 1.410.8 ± 1.50.3 ± 0.50.308.2 ± 1.87.9 ± 1.8-0.4 ± 0.70.20
ECD9.9 ± 1.510.9 ± 1.61.0 ± 0.59.8 ± 1.810.7 ± 1.80.9 ± 0.7
Body weight (kg)Mini-LCD67.1 ± 2.466.3 ± 2.565.8 ± 2.466.0 ± 2.4-1.1 ± 0.30.0459.2 ± 3.058.3 ± 3.058.7 ± 3.058.7 ± 3.1-0.5 ± 0.40.99
ECD58.2 ± 2.558.0 ± 2.657.9 ± 2.558.0 ± 2.50-0.3 ± 0.360.7 ± 2.860.2 ± 3.060.2 ± 3.060.1 ± 3.1-0.5 ± 0.4
Energy intake (kcal/day)Mini-LCD1,548.4 ± 79.21,556.2 ± 69.71,513.8 ± 101.31,558.5 ± 84.1-18.7 ± 91.70.421,555.1 ± 90.81,601.2 ± 85.41,404.8 ± 72.01,520.3 ± 87.2-21.1 ± 95.10.29
ECD1,661.3 ± 77.11,647.1 ± 66.01,725.6 ± 96.01,538.8 ± 79.5-122.5 ± 86.71,631.0 ± 91.01,566.6 ± 85.41,546.3 ± 72.01,468.0 ± 87.2-182.4 ± 105.1
Carbohydrate intake (g/day)Mini-LCD200.2 ± 13.4 (51.1± 2.0%)208.4 ± 10.0 (53.5± 1.9%)190.9 ± 13.1 (50.8± 1.5%)194.9 ± 11.2 (50.3± 1.3%)-9.4 ± 15.40.62197.8 ± 17.6 (53.1± 2.0%)202.1 ± 14.1 (48.8± 2.5%)184.1 ± 39.5 (51.1± 1.5%)185.7 ± 11.8 (51.0±2.9%)-9.1 ± 19.30.59
ECD232.8 ± 13.0 (56.1± 2.0%)227.7 ± 9.5 (56.0± 1.9%)247.2 ± 12.5 (57.7± 1.5%)212.8 ± 10.5 (55.5± 1.2%)-20.0 ± 14.6226.3 ± 18.0 (57.2± 2.0%)212.4 ± 14.1 (56.0± 2.5%)216.9 ± 38.2 (53.7± 1.5%)201.1 ± 11.8 (55.9±20.9%)-24.0 ± 21.3
Protein intake (g/day)Mini-LCD68.4 ± 3.7 (18.1± 0.7%)67.8 ± 5.0 (17.4± 0.9%)66.2 ± 3.8 (17.8± 0.7%)66.2 ± 3.8 (18.4± 0.6%)1.5 ± 4.10.1666.7 ± 4.1 (17.5± 1.3%)70.1 ± 5.2 (18.0± 1.2%)66.5 ± 3.6 (18.5± 0.9%)71.5 ± 4.4 (20.6±1.5%)5.2 ± 3.90.0085
ECD68.3 ± 3.6 (16.4± 0.7%)66.7 ± 4.7 (16.1± 0.9%)63.1 ± 3.6 (14.7± 0.7%)63.1 ± 3.6 (16.1± 0.6%)-6.5 ± 3.967.5 ± 4.1 (17.0± 1.3%)64.3 ± 5.2 (16.3± 1.2%)67.9 ± 3.6 (16.0± 0.9%)58.3 ± 4.4 (17.3±1.5%)-10.1 ± 4.3
Fat intake (g/day)Mini-LCD47.4 ± 3.5 (27.8± 1.4%)49.9 ± 4.0 (29.1± 1.6%)52.7 ± 5.2 (30.8± 1.9%)52.3 ± 3.7 (30.1± 1.2%)4.4 ± 3.80.3446.7 ± 3.7 (25.4± 2.0%)55.2 ± 4.3 (31.7± 1.9%)45.5 ± 3.9 (28.2± 1.5%)53.9 ± 4.2 (26.2± 2.6%)6.4 ± 4.50.27
ECD47.6 ± 3.4 (25.8± 1.4%)49.4 ± 3.8 (26.8± 1.5%)50.9 ± 4.9 (26.3± 1.5%)47.0 ± 3.5 (27.4± 1.2%)-0.6 ± 3.645.8 ± 3.7 (23.9± 2.0%)50.3 ± 4.3 (26.5±1.9%)46.6 ± 3.9 (29.0±1.5%)43.2 ± 4.7 (25.3±2.6%)-2.4 ± 5.0
LDL-C (mg/dL)Mini-LCD113.2 ± 5.4116.1 ± 6.9116.8 ± 0.1110.0 ± 6.2-3.2 ± 5.30.98107.0 ± 6.6116.2 ± 11.0117.8 ± 11.1104.0 ± 9.8-2.9 ± 9.80.83
ECD115.7 ± 5.6110.9 ± 7.0116.8 ± 0.1112.3 ± 6.5-3.4 ± 5.5131.0 ± 6.7125.2 ± 11.0126.2 ± 11.0125.1 ± 10.0-5.9 ± 9.8
HDL-C (mg/dL)Mini-LCD60.2 ± 3.360.1 ± 3.161.2 ± 2.959.5 ± 4.3-0.72 ± 2.30.3765.3 ± 6.064.9 ± 14.364.4 ± 5.163.5 ± 8.3-1.8 ± 4.50.28
ECD60.9 ± 3.460.5 ± 3.258.6 ± 3.063.2 ± 4.52.3 ± 2.462.3 ± 6.080.3 ± 14.258.1 ± 5.167.5 ± 8.35.2 ± 4.5
TG (mg/dL)Mini-LCD158 (122 - 194)141 (118 - 165)128 (97 - 160)143 (16 - 112)-14.9 ± 16.10.36173 (110 - 236)135 (95 - 175)152 (77 - 227)168 (95 - 240)-5.4 ± 20.60.42
ECD121 (89 - 164)119 (93 - 145)137 (105 - 168)133 (16 - 100)6.5 ± 16.8114 (52 - 177)119 (79 - 158)152 (77 - 227)133 (660 - 206)18.4 ± 20.6
Ketones (µmol/L)Mini-LCD71.4 ± 9.7101.7 ± 23.729.5 ± 24.60.8289.1 ± 15.385.6 ± 27.3-3.5 ± 32.10.60
ECD62.8 ± 10.482.3 ± 26.020.8 ± 27.666.8 ± 15.387.1 ± 27.320.3 ± 32.1
DTSQ totalMini-LCD24.1 ± 2.229.7 ± 0.95.6 ± 2.20.7926.3 ± 3.430.8 ± 1.18.4 ± 2.90.53
ECD25.5± 2.430.0 ± 0.94.7 ± 2.422.8 ± 3.730.5 ± 1.211.3 ± 3.2
DTSQ Q2Mini-LCD2.1 ± 0.32.7 ± 0.3-0.2 ± 0.40.412.7 ± 0.62.4 ± 4.3-0.3 ± 0.50.34
ECD1.7 ± 0.31.7 ± 0.3-0.7 ± 0.42.2 ± 0.71.8 ± 4.5-0.4 ± 0.6
DTSQ Q3Mini-LCD1.3 ± 0.21.7 ± 0.20.4 ± 0.40.211.0 ± 0.21.3± 0.10.3 ± 0.30.36
ECD1.4 ± 0.21.2 ± 0.3-0.3 ± 0.41.2 ± 0.21.2 ± 0.14-0.1 ± 0.3
Waist circumference (cm)Mini-LCD88.2 ± 1.787.8 ± 1.7-0.7 ± 1.20.3584.3 ± 2.784.2 ± 3.7-0.08±2.70.60
ECD81.0 ± 1.878.9 ± 1.8-2.3 ± 1.284.2 ± 2.782.1 ± 3.7-2.1 ± 2.7
Basal energy expenditure (kcal/day)Mini-LCD1,338.7 ± 43.11,342.6 ± 41.80.9 ± 3.20.231,228.0 ± 52.61,234.1 ± 52.86.1 ± 4.70.57
ECD1,278.1 ± 44.91,261.9 ± 44.76.8 ± 3.51,320.7 ± 52.61,323.0 ± 52.82.3 ± 4.7
Fat mass (%)Mini-LCD32.3 ± 1.731.0 ± 1.7-1.2 ± 0.50.5032.2 ± 2.631.0 ± 2.53-1.2 ± 0.60.44
ECD28.7 ± 1.825.9 ± 1.8-1.7 ± 0.629.4 ± 2.628.9 ± 2.5-0.6 ± 0.6
Muscle mass (kg)Mini-LCD24.4 ± 1.224.2 ± 1.4-0.01 ± 0.10.5921.3 ± 1.521.6 ± 1.50.28 ± 0.100.086
ECD22.8 ± 1.322.3 ± 1.3-0.3 ± 0.123.9 ± 1.524.0 ± 1.50.03 ± 0.10