Fig. 1Study design. Participants took fiber for 4 weeks and stopped for the next 4 weeks to evaluate restoration. Glycemic parameters, incretin levels during mixed-meal tolerance test (MMTT), and fecal microbiota were analyzed at weeks 0, 4, and 8 to evaluate baseline status, the immediate change after AGIO (Bukwang Pharmaceutical Co. Ltd.) intake, and restoration, respectively.
Fig. 2Area under the curves (AUCs) during mixed-meal tolerance test (MMTT) by week. AUCs during MMTT were compared at each week. Differences between each visit were analyzed by use of the Wilcoxon signed-rank test, and multiple comparisons were corrected with Bonferroni's method. There were no statistically significant changes in variables over the study period. GIP, gastric inhibitory polypeptide; GLP, glucagon-like peptide; PYY, peptide YY.
Table 1Baseline characteristics of all participants (n=10)
Variable |
Value |
Age, yr |
61 (57–71.5) |
Male sex |
6 (60) |
T2DM duration, yr |
15 (11.5–18.3) |
Glycosylated hemoglobin, % |
8.0 (7.6–8.3) |
Glycoalbumin, % |
19.8 (17.0–27.3) |
Metformin, mg/day |
1,000 (850–1,700) |
Glimepiride, mg/day |
2.5 (1.8–6) |
HTN |
6 (60) |
BMI, kg/m2
|
25.8 (23.3–28.2) |
SBP, mm Hg |
139 (127.8–151.8) |
DBP, mm Hg |
87 (85–89) |
FPG, mg/dL |
161.5 (147.3–207.3) |
Insulin, μIU/mL |
5.7 (4.1–9.6) |
C-peptide, ng/mL |
1.9 (1.5–3.2) |
Total cholesterol, mg/dL |
158 (133.8–189.3) |
Triglyceride, mg/dL |
105 (85.5–153) |
HDL, mg/dL |
48 (38.5–62.8) |
LDL, mg/dL |
96 (80.3–124.3) |
CRP, mg/dL |
0.05 (0.03–0.06) |
Carbohydrate, g/day |
225.9 (217.6–279.9) |
Fat, g/day |
45.0 (26.2–52.3) |
Fiber, g/day |
25.6 (19.5–32.8) |
Table 2Primary and secondary laboratory outcomes of all participants
Variable |
Week 0 |
Week 4 |
Week 8 |
Glycoalbumin |
19.8 (17.0–27.3) |
19.4 (17.4–25.7) |
21.1 (17.3–25.5) |
Insulinogenic index |
0.2 (0.1–0.3) |
0.1 (0.1–0.3) |
0.1 (0.1–0.3) |
QUICKI |
0.34 (0.30–0.36) |
0.31 (0.30–0.35) |
0.34 (0.30–0.35) |
HOMA2-IR |
0.8 (0.6–1.5) |
1.3 (0.8–1.6) |
1.0 (0.6–1.5) |
Matsuda index |
4.1 (2.3–5.2) |
2.6 (2.2–4.9) |
3.4 (2.5–4.9) |
Disposition index |
0.5 (0.39–0.90) |
0.4 (0.4–0.9) |
0.6 (0.4–0.9) |
LPS (log) |
81.0 (47.4–259.2) |
72.0 (32.8–455.7) |
93.7 (45.3–376.6) |
Table 3Comparison between the ‘responders’ and the ‘nonresponders’
Variable |
Responders (patients 1, 7, 13) |
Nonresponders (patients 5, 9, 14) |
Week 0 |
Week 4 |
Week 8 |
Week 0 |
Week 4 |
Week 8 |
Age, yr |
56 (57–73) |
|
|
59 (57–61) |
|
|
Male sex |
2 (66.7) |
|
|
3 (100) |
|
|
DM duration, yr |
13 (12–14) |
|
|
16 (10–19) |
|
|
HbA1c, %a
|
7.8 (7.0–7.9) |
|
|
8.2 (8.1–8.6) |
|
|
Metformin, mg/day |
1,000 (1,000–1,700) |
|
|
850 (850–2,000) |
|
|
Glimepiride, mg/day |
6 (2–6) |
|
|
4 (1–6) |
|
|
HTN |
1 (33.3) |
|
|
1 (33.3) |
|
|
BMI, kg/m2
|
24.8 (19.2–28.0) |
25.4 (20–27.4) |
25.2 (20.2–27.7) |
26.6 (26.6–33.2) |
26.6 (26.4–32.7) |
26.8 (26.2–32.3) |
SBP, mm Hg |
136 (124–155) |
144 (121–149) |
127 (110–171) |
133 (128–151) |
131 (122–154) |
140 (112–144) |
DBP, mm Hg |
85 (74–88) |
89 (76–92) |
84 (67–103) |
89 (87–93) |
91 (68–93) |
79 (65–83) |
FPG, mg/dL |
150 (142–232) |
148 (133–243) |
172 (162–201) |
170 (117–217) |
167 (161–278) |
191 (154–218) |
Insulin, μIU/mL |
4.1 (4.0–13.1) |
3.9 (3.5–11.6) |
4.2 (1.0–10.1) |
5.6 (4.1–8.4) |
8.3 (6.1–9.5) |
7.0 (3.8–9.8) |
C-peptide, ng/mL |
1.7 (1.3–4.3) |
1.6 (1.5–4.3) |
2.1 (1.3–4.2) |
2.1 (2.0–2.8) |
2.2 (2.2–2.9) |
2.3 (2.3–3.3) |
Total cholesterol, mg/dL |
135 (130–221) |
171 (144–215) |
151 (145–245) |
158 (158–158) |
185 (183–189) |
188 (171–190) |
Triglyceride, mg/dL |
86 (67–159) |
136 (109–169) |
102 (102–151) |
97 (89–151) |
101 (90–203) |
88 (84–242) |
HDL, mg/dL |
62 (30–65) |
60 (32–65) |
63 (41–76) |
48 (44–48) |
53 (52–56) |
54 (43–55) |
LDL, mg/dL |
81 (58–149) |
91 (86–144) |
80 (74–158) |
96 (94–101) |
131 (109–134) |
128 (99–131) |
Carbohydrate, g/day |
248.6 (216.4–288.8) |
245.6 (220.6–312.9) |
285.5 (254.7–367.1)a
|
278.0 (218–285.5) |
262.1 (219.9–342.3) |
227.6 (200.5–238.5)a
|
Fat, g/day |
44 (25.4–87.1) |
45.6 (24.4–45.6) |
51.4 (18.6–64.8) |
45.9 (32.1–54.1) |
52.0 (39.6–60.5) |
31.5 (15.6–50.4) |
Fiber, g/day |
32.6 (14.8–33.2) |
32.9 (16.4–34.6) |
33.6 (18.1–39.1) |
22.5 (21–31.9) |
21.6 (21.3–23.1) |
21.6 (13.1–22.8) |
Insulinogenic index |
0.09 (0.05–0.15) |
0.06 (0.06–0.16) |
0.08 (0.04–0.14) |
0.18 (0.17–0.36) |
0.15 (0.10–0.48) |
0.20 (0.15–0.61) |
QUICKI |
0.36 (0.29–0.36) |
0.37 (0.29–0.37) |
0.35 (0.30–0.46) |
0.35 (0.31–0.36) |
0.31 (0.30–0.33) |
0.33 (0.30–0.35) |
Matsuda index |
5.02 (2.00–5.55) |
5.59 (2.24–6.86) |
4.22 (2.99–12.88) |
4.11 (2.45–6.99) |
2.41 (1.97–4.37) |
2.54 (2.41–5.62) |
HOMA2-IR |
0.60 (0.58–2.10) |
0.56 (0.51–1.84) |
0.63 (0.15–1.55) |
0.78 (0.61–1.32) |
1.39 (0.90–1.49) |
1.02 (0.58–1.52) |
Disposition index |
0.49 (0.10–0.77) |
0.43 (0.14–0.87) |
0.57 (0.12–1.00) |
1.27 (0.41–1.47) |
0.42 (0.35–0.94) |
0.83 (0.48–1.55) |
Glycoalbumin, % |
18.8 (17.0–28.9) |
18.4 (16.1–26.6) |
18.5 (17–25.4) |
19.8 (14.9–26.8) |
20.2 (15.1–25.0) |
21.4 (14.8–23.9) |
LPS (log) |
92.8 (36.6–524.5) |
81.4 (19.3–453.8) |
92.1 (20.0–362.9) |
69.3 (42.4–606.4) |
62.7 (57.3–596.8) |
95.3 (47.2–600.0) |