1Division of Endocrinology and Metabolism, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea
2Department of Family Medicine, Konyang University College of Medicine, Daejeon, Korea
3Department of Endocrinology and Metabolism, College of Medicine, Kyung Hee University, Seoul, Korea
Copyright © 2022 Korean Diabetes Association
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Study | Intervention diet | Control diet | No. of subject | %DM patient | Dropout rate, C/I |
Nation | Age, yr | BW, kg | BMI, kg/m2 | DM duration, yr | HbA1c, % | TG, mg/dL | LDL-C, mg/dL | HDL-C, mg/dL |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kimura et al. (2018) [5] | MCD | CRD | 48 | 100% | 4.3%/4% | Japan | 64.8 | 62.8 | 24.8 | 12.2 | 7.0 | 140.3 | 114.4 | 60.5 |
Larsen et al. (2011) [6] | MCD | HCD | 99 | 100% | 2.2%/9.4% | Australia | 57.2 | 95.0 | NA | 8.7 | 7.8 | 210.8 | 95.1 | 46.2 |
Liu et al. (2018) [7] | MCD | SD | 122 | 100% | 16.3%/16.3% | China | 50.4 | 58.5 | 21.4 | 0.0 (new) | 7.1 | 116.9 | 79.9 | 56.7 |
Wang et al. (2018) [8] | MCD | LFD | 48 | 100% | 4.3%/4% | China | 64.8 | 62.8 | 24.8 | 12.2 | 7.0 | 140.3 | 114.4 | 60.5 |
Chen et al. (2020) [9] | LCD | SD | 85 | 100% | 6.7%/8.5% | Taiwan | 63.5 | 69 | 26.9 | 9.9 | 8.6 | 170.7 | 103.4 | 45.4 |
Daly et al. (2006) [10] | LCD | LFD | 102 | 100% | 27.5%/27.5% | UK | 58.7 | 102 | 36.1 | NA | 9.1 | 224.1 | NA | 46.8 |
Davis et al. (2009) [11] | LCD | LFD | 105 | 100% | 12%/14.6% | USA | 53.5 | 97.1 | 36.0 | NA | 7.5 | 124 | 94.8 | 48.4 |
Guldbrand et al. (2012) [12], Jonasson et al. (2014) [13] | LCD | LFD | 61 | 100% | 10%/13% | Sweden | 62.0 | 95.2 | 32.7 | 9.3 | 7.3 | 155.3 | 97.7 | 42.6 |
Morris et al. (2020) [14] | LCD | SD | 33 | 100% | 8.3%/0% | UK | 67.0 | 101 | 35.4 | 9.2 | 7.7 | 172.7 | NA | 45.2 |
Perna et al. (2019) [15] | LCD | CRD | 17 | 100% | 0% | Bahrain | 63.9 | 85.3 | 31.4 | NA | 6.0 | 156.5 | 100.2 | 47.4 |
Sato et al. (2017) [16] | LCD | CRD | 66 | 100% | 3%/9% | Japan | 59.5 | 73.8 | 26.6 | 13.5 | 8.2 | 145.5 | 99.3 | 45.3 |
Shai et al. (2008) [17], Yokose et al. (2020) [18] | LCD | LFD | 213 (36a) | 16.9% | 9.6%/22.0% | Israel | NA | 91.4 | 30.9 | NA | NA | 170.8 | 119 | 38.5 |
Struik et al. (2020) [19], Wycherley et al. (2016) [20], Tay et al. (2015) [21], Tay et al. (2018) [22], Tay et al. (2014) [23] | LCD | LFD | 115 | 100% | 18%/21% | Australia | 58.0 | 101.6 | 34.6 | 8.0 | 7.3 | 132.9 | 92.8 | 51 |
Dyson et al. (2007) [24] | VLCD | CRD | 26 | 65% | 28.6%/0% | UK | 52.0 | 96.3 | 35.1 | NA | 6.6 | 131.1 | 119.9 | 51 |
Goday et al. (2016) [25] | VLCD | CRD | 89 | 100% | 18.2%/11.1% | Spain | 54.5 | 90.5 | 33.1 | NA | 6.9 | 155.2 | 106.3 | 53 |
Goldstein et al. (2011) [26] | VLCD | CRD | 52 | 100% | 38.5%/46.2% | Israel | 56.0 | 92 | 33.2 | 8.0 | 8.9 | 200.5 | NA | 44 |
Iqbal et al. (2010) [27] | VLCD | LFD | 144 | 100% | 43%/60% | USA | 60.0 | 116.9 | 37.5 | NA | 7.7 | 161.1 | 107.7 | 40.7 |
Saslow et al. (2017) [28] | VLCD | LFD | 34 | 50% | 16.7%/12.5% | USA | 59.7 | 98.6 | 36.4 | 7.0 | 6.8 | 132.4 | 93.7 | 47 |
Outcomes | Illustrative comparative effects |
No. of participants | Quality of the evidence (GRADE) | ||
---|---|---|---|---|---|
Assumed effect |
Corresponding effects |
||||
Control | mLCD | Mean difference | |||
HbA1c, % (follow-up: 8–24 weeks) | –0.20 | –0.41 | –0.21 (–0.32 to –0.10) | 758 (10 studies) | Moderate |
HOMA-IR (follow-up: 8–24 weeks) | –0.40 | –0.93 | –0.53 (–0.96 to –0.11) | 248 (3 studies) | Low |
Fasting glucose, mg/dL (follow-up: 8–24 weeks) | 4.65 | –5.23 | –9.88 (–18.04 to –1.71) | 337 (6 studies) | Low |
Body weight, kg (follow-up: 8–24 weeks) | –1.45 | –2.99 | –1.54 (–3.11 to 0.02) | 619 (8 studies) | Low |
Systolic blood pressure, mm Hg (follow-up: 8–24 weeks) | –0.25 | –3.24 | –2.99 (–5.48 to –0.49) | 510 (6 studies) | Moderate |
Diastolic blood pressure, mm Hg (follow-up: 8–24 weeks) | 0.55 | –0.52 | –1.07 (–2.43 to 0.29) | 513 (6 studies) | Low |
Triglycerides, mg/dL (follow-up: 8–24 weeks) | –4.00 | –21.22 | –17.22 (–34.27 to –0.18) | 742 (10 studies) | Low |
LDL-C, mg/dL (follow-up: 8–24 weeks) | –3.60 | –3.25 | 0.35 (–3.03 to 3.72) | 607 (8 studies) | Low |
HDL-C, mg/dL (follow-up: 8–24 weeks) | 0.20 | 2.50 | 2.30 (0.23 to 4.37) | 547 (8 studies) | Moderate |
Hypoglycemia | There is no study directly evaluated the risk of hypoglycemia. Patients at high risk of hypoglycemia were excluded in 2 out of 13 studies. |
Outcomes | Illustrative comparative effects |
No. of participants | Quality of the evidence (GRADE) | ||
---|---|---|---|---|---|
Assumed effect |
Corresponding effects |
||||
Control | VLCD | Mean difference | |||
HbA1c, % (follow-up: 8–24 weeks) | –0.20 | –0.56 | –0.36 (–0.54 to –0.19) | 321 (5 studies) | Moderate |
HOMA-IR (follow-up: 8–24 weeks) | –0.45 | –1.52 | –1.07 (–3.13 to 0.98) | 119 (2 studies) | Low |
Fasting glucose, mg/dL (follow-up: 8–24 weeks) | –17.20 | –26.84 | –9.64 (–19.54 to 0.26) | 267 (3 studies) | Low |
Body weight, kg (follow-up: 8–24 weeks) | –3.40 | –7.24 | –3.84 (–7.55 to –0.13) | 291 (4 studies) | Moderate |
Systolic blood pressure, mm Hg (follow-up: 8–24 weeks) | –1.70 | –1.36 | 0.34 (–3.61 to 4.28) | 218 (3 studies) | Low |
Diastolic blood pressure, mm Hg (follow-up: 8–24 weeks) | –2.50 | –1.12 | 1.38 (–0.90 to 3.67) | 218 (3 studies) | Low |
Triglycerides, mg/dL (follow-up: 8–24 weeks) | –15.70 | –27.10 | –11.40 (–27.01 to 4.22) | 313 (5 studies) | Low |
LDL-C, mg/dL (follow-up: 8–24 weeks) | –1.35 | 5.84 | 7.19 (0.02 to 14.36) | 277 (4 studies) | Moderate |
HDL-C, mg/dL (follow-up: 8–24 weeks) | 2.30 | 2.73 | 0.43 (–1.98 to 2.84) | 312 (5 studies) | Low |
Hypoglycemia | Although no study directly evaluated the risk of hypoglycemia, patients at high risk of hypoglycemia were excluded in 4 out of 5 studies. |
Energy, kcal/day |
Carbohydrate, g/day |
Fat, g/day |
Protein, g/day |
|||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | <6 mo | 6 mo–1 yr | >1 yr | Baseline | <6 mo | 6 mo–1 yr | >1 yr | Baseline | <6 mo | 6 mo–1 yr | >1 yr | Baseline | <6 mo | 6 mo–1 yr | >1 yr | |||
mLCD | Chen et al. (2020) [9] | Control | 1,776.1 | 1,463.2 | 238.2 | 151.1 | 64.3 | 67.2 | 73.2 | 72.0 | ||||||||
Intervention | 1,735.5 | 1,424.8 | 244.1 | 88.0 | 56.7 | 73.1 | 70.9 | 82.4 | ||||||||||
Difference |
–38.5 | –63.1 | 5.9 | 10.4 | ||||||||||||||
Daly et al. (2006) [10] | Control | 168.6 | 52.4 | 59.9 | ||||||||||||||
Intervention | 1,290.0 | 109.5 | 57.5 | 68.1 | ||||||||||||||
Difference |
–144.0 | –59.1 | 5.1 | 8.2 | ||||||||||||||
Davis et al. (2009) [11] | Control | 1,863.0 | 1,653.0 | 1,810.0 | 191.9 | 198.8 | 226.7 | 80.3 | 56.6 | 61.9 | 72.3 | 67.8 | 68.4 | |||||
Intervention | 1,983.0 | 1,652.0 | 1,642.0 | 217.6 | 138.4 | 137.1 | 79.5 | 78.9 | 80.1 | 77.3 | 74.3 | 74.5 | ||||||
Difference |
–1.0 | –168.0 | –60.4 | –89.6 | 22.4 | 18.2 | 6.6 | 6.1 | ||||||||||
Guldbrand et al. (2012) [12] | Control | 1,802.1 | 1,547.1 | 1,576.0 | 1,453.3 | 216.3 | 189.5 | 185.2 | 170.8 | 64.1 | 49.9 | 54.3 | 50.1 | 68.5 | 65.0 | 63.0 | 58.1 | |
Intervention | 1,683.6 | 1,378.8 | 1,432.6 | 1,246.2 | 172.6 | 86.2 | 96.7 | 96.6 | 73.0 | 75.1 | 74.8 | 60.9 | 64.0 | 68.8 | 65.9 | 59.8 | ||
Difference |
–168.3 | –143.3 | –207.1 | –103.3 | –88.5 | –74.2 | 25.2 | 20.5 | 10.9 | 3.8 | 2.9 | 1.7 | ||||||
Kimura et al. (2018) [5] | Control | 1,661.3 | 1,725.6 | 232.8 | 212.8 | 47.6 | 47.0 | 68.3 | 63.1 | |||||||||
Intervention | 1,548.4 | 1,513.8 | 200.2 | 194.9 | 47.4 | 52.3 | 68.4 | 66.2 | ||||||||||
Difference |
–211.8 | –17.9 | 5.3 | 3.1 | ||||||||||||||
Larsen et al. (2011) [6] | Control | 2,184.5 | 1,435.5 | 1,578.1 | 248.5 | 175.8 | 190.2 | 79.6 | 46.7 | 56.1 | 88.7 | 59.7 | 59.7 | |||||
Intervention | 2,118.3 | 1,535.5 | 1,586.7 | 234.9 | 155.1 | 165.8 | 75.8 | 51.4 | 54.1 | 89.1 | 86.6 | 84.2 | ||||||
Difference |
100.0 | 8.6 | –20.7 | –24.4 | 4.6 | –2.0 | 26.9 | 24.5 | ||||||||||
Liu et al. (2018) [7] | Control | 1,805.3 | 1,739.4 | 229.7 | 226.7 | 58.6 | 54.6 | 73.6 | 74.9 | |||||||||
Intervention | 1,803.0 | 1,789.6 | 233.8 | 172.8 | 56.1 | 56.4 | 68.2 | 134.1 | ||||||||||
Difference |
50.2 | –53.8 | 1.7 | 59.1 | ||||||||||||||
Morris et al. (2020) [14] | Not available | |||||||||||||||||
Perna et al. (2019) [15] | Control | 1,566.0 | 241.0 | 42.3 | 74.3 | |||||||||||||
Intervention | 1,570.0 | 125.0 | 81.4 | 87.1 | ||||||||||||||
Difference |
4.0 | –116.0 | 39.1 | 12.8 | ||||||||||||||
Sato et al. (2017) [16] | Control | 1,686.0 | 1,605.0 | 211.0 | 198.0 | 54.0 | 52.0 | 61.0 | 63.0 | |||||||||
Intervention | 1,729.0 | 1,371.0 | 223.0 | 149.0 | 54.0 | 52.0 | 64.0 | 64.0 | ||||||||||
Difference |
–234.0 | –49.0 | 0.0 | 1.0 | ||||||||||||||
Shai et al. (2008) [17] |
Control | –458.3 | –559.1 | –572.6 | –69.1 | –83.4 | –82.8 | –14.7 | –18.0 | –18.9 | –12.8 | –16.7 | –19.8 | |||||
Intervention | –560.8 | –591.1 | –550.0 | –123.6 | –127.7 | –129.8 | –3.6 | –4.8 | –1.7 | –10.2 | –11.8 | –6.9 | ||||||
Difference |
–102.5 | –32.0 | 22.6 | –54.5 | –44.3 | –47.0 | 11.1 | 13.2 | 17.2 | 2.6 | 4.9 | 12.9 | ||||||
Tay et al. (2014) [23] | Control | 1,628.0 | 1,708.0 | 1,757.0 | 209.0 | 216.0 | 216.0 | 45.0 | 50.0 | 55.0 | 75.0 | 77.0 | 79.0 | |||||
Intervention | 1,596.0 | 1,683.0 | 1,707.0 | 60.0 | 74.0 | 83.0 | 98.0 | 100.0 | 98.0 | 103.0 | 106.0 | 105.0 | ||||||
Difference |
–32.0 | –25.0 | –50.0 | –149.0 | –142.0 | –133.0 | 53.0 | 50.0 | 43.0 | 28.0 | 29.0 | 26.0 | ||||||
Wang et al. (2018) [8] | Control | 1,768.8 | 1,731.5 | 230.6 | 242.6 | 60.2 | 49.2 | 60.7 | 63.5 | |||||||||
Intervention | 1,796.0 | 1,808.0 | 237.2 | 173.8 | 59.9 | 84.8 | 61.3 | 70.1 | ||||||||||
Difference |
76.5 | –68.8 | 35.6 | 6.6 | ||||||||||||||
VLCD | Dyson et al. (2007) [24] | Control | 2,130.00 | 1,593.00 | 223.2 | 167.3 | 92.5 | 62.7 | 95.2 | 79.5 | ||||||||
Intervention | 1,313.0 | 56.8 | 69.3 | 97.2 | ||||||||||||||
Difference |
–280.0 | –110.5 | 6.6 | 17.7 | ||||||||||||||
Goday et al. (2016) [25] | Not available | |||||||||||||||||
Goldstein et al. (2011) [26] | Control | 2,599.0 | 1,909.0 | 1,937.0 | 248.0 | 190.0 | 208.0 | 128.0 | 87.0 | 85.0 | 119.0 | 91.0 | 90.0 | |||||
Intervention | 2,261.0 | 1,721.0 | 1,725.0 | 213.0 | 93.0 | 85.0 | 112.0 | 109.0 | 111.0 | 105.0 | 96.0 | 102.0 | ||||||
Difference |
–188.0 | –212.0 | –97.0 | –123.0 | 22.0 | 26.0 | 5.0 | 12.0 | ||||||||||
Iqbal et al. (2010) [27] | Control | 2,144.1 | 1,733.8 | 1,628.2 | 1,573.5 | 231.6 | 181.6 | 175.0 | 183.7 | 93.1 | 70.5 | 65.9 | 58.6 | 75.9 | 73.2 | 66.1 | 55.4 | |
Intervention | 2,007.0 | 1,806.2 | 1,659.5 | 1,609.9 | 201.2 | 159.8 | 167.2 | 192.8 | 88.8 | 85.7 | 65.6 | 61.2 | 77.1 | 70.4 | 66.7 | 54.4 | ||
Difference |
72.4 | 31.3 | 36.4 | –21.8 | –7.8 | 9.1 | 15.2 | –0.2 | 2.6 | –2.7 | 0.6 | –1.0 | ||||||
Saslow et al. (2017) [28] | Control | 2,063.1 | 1,483.5 | 1,681.1 | 184.4 | 160.7 | 149.8 | 86.3 | 55.8 | 75.4 | 91.4 | 82.4 | 68.8 | |||||
Intervention | 1,954.1 | 1,589.4 | 1,534.8 | 176.2 | 44.1 | 73.7 | 79.2 | 101.4 | 105.4 | 82.7 | 92.2 | 97.6 | ||||||
Difference |
105.9 | –146.3 | –116.6 | –76.1 | 45.6 | 30.0 | 9.8 | 28.8 |
DM, diabetes mellitus; C/I, control/intervention group; BW, body weight; BMI, body mass index; HbA1c, glycosylated hemoglobin; TG, triglyceride; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; MCD, moderately-low-diet; CRD, calorie-restricted diet; HCD, high-carbohydrate diet; SD, standard diet; LFD, low fat diet; LCD, low-carbohydrate diet; NA, not available; VLCD, very-low-carbohydrate diet. Number of patients with diabetes among total subjects.
mLCD for type 2 diabetes mellitus; Patient or population: patients with type 2 diabetes mellitus; Intervention: mLCD. GRADE Working Group grades of evidence: High quality (Further research is very unlikely to change our confidence in the estimate of effect); Moderate quality (Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate); Low quality (Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate); Very low quality (We are very uncertain about the estimate). mLCD, moderately-low-carbohydrate or low-carbohydrate diet; CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; HbA1c, glycosylated hemoglobin; HOMA-IR, homeostatic model assessment for insulin resistance; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol. The assumed effect is the mean change of outcomes compared to baseline in the control group. The corresponding effects are the mean change of outcomes compared to baseline in the intervention group and the mean difference (and its 95% CI) between control and intervention group.
VLCD for type 2 diabetes mellitus; Patient or population: patients with type 2 diabetes mellitus; Intervention: VLCD. GRADE Working Group grades of evidence: High quality (Further research is very unlikely to change our confidence in the estimate of effect); Moderate quality (Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate); Low quality (Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate); Very low quality (We are very uncertain about the estimate). VLCD, very-low-carbohydrate diet; CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; HbA1c, glycosylated hemoglobin; HOMA-IR, homeostatic model assessment for insulin resistance; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol. The assumed effect is the mean change of outcomes compared to baseline in the control group. The corresponding effects are the mean change of outcomes compared to baseline in the intervention group and the mean difference (and its 95% CI) between control and intervention group.
mLCD, moderately-low-carbohydrate or low-carbohydrate diet; VLCD, very-low-carbohydrate diet. Difference between the control group and the intervention group at the time point, Each value had presented the changes from baseline, not the value at the time point.