Not in remission at 48 weeks (n=11) | In remission at 48 weeks (n=14) | p Value | |
---|---|---|---|
Demographics | |||
Age (years) | 58.5±7.4 | 56.5±7.6 | 0.52 |
Gender (% male) | 63.6 | 64.3 | 0.97 |
Ethnicity | 0.08 | ||
White (%) | 45.5 | 85.7 | |
Other (%) | 54.5 | 14.3 | |
Duration of diabetes (years) | 2.6±1.8 | 1.2±1.0 | 0.03 |
Duration of diabetes | 0.03 | ||
<1 year, n (%) | 2 (18.2) | 5 (35.7) | |
1–2 years, n (%) | 1 (9.1) | 6 (42.9) | |
≥2 years, n (%) | 8 (72.7) | 3 (21.4) | |
Diabetes therapy prior to study | 0.49 | ||
Diet alone (%) | 27.3 | 35.7 | |
Metformin alone (%) | 63.6 | 64.3 | |
Metformin+sulfonylurea (%) | 9.1 | 0 | |
Baseline metabolic status (pre-IIT) | |||
Body mass index (kg/m2) | 30.0±4.7 | 31.5±6.8 | 0.54 |
Waist circumference (cm) | 103.5±12.3 | 105.0±15.0 | 0.79 |
Systolic blood pressure (mm Hg) | 126±14 | 122±10 | 0.50 |
Diastolic blood pressure (mm Hg) | 70±9 | 68±8 | 0.60 |
Alanine aminotransferase (IU/L) | 31±14 | 30±11 | 0.80 |
Aspartate aminotransferase (IU/L) | 25 (17–28) | 22 (20–26) | 0.84 |
γ-Glutamyl transferase (IU/L) | 36 (26–91) | 24 (21–37) | 0.12 |
Glycemia | |||
Fasting plasma glucose (mmol/L) | 6.5±1.3 | 5.9±0.8 | 0.20 |
A1c (%) | 7.1±0.9 | 6.2±0.5 | 0.006 |
Insulin sensitivity/resistance | |||
Matsuda index | 4.9 (2.8–7.1) | 5.8 (3.5–9.0) | 0.70 |
HOMA-IR | 5.0 (2.9–7.2) | 3.4 (2.3–6.1) | 0.36 |
Glucagon profile | |||
Fasting glucagon (pg/mL) | 122±32 | 105±37 | 0.26 |
AUCglucagon | 535±139 | 470±85 | 0.17 |
β-Cell function | |||
ISSI-2 | 206 (145–233) | 251 (210–341) | 0.01 |
ΔISR0–120/Δgluc0–120×Matsuda index | 0.14 (0.07–0.19) | 0.22 (0.14–0.48) | 0.02 |
IIT phase | |||
Final daily basal insulin dosage (U/kg) | 0.36 (0.20–0.63) | 0.14 (0.10–0.31) | 0.002 |
Final daily meal insulin dosage (U/kg) | 0.27 (0.17–0.56) | 0.12 (0.08–0.19) | 0.01 |
Hypoglycemia | |||
Any hypoglycemia (per person year) | 0.20 (0–0.62) | 0 (0–0.20) | 0.71 |
Number of severe episodes | 0 | 0 | 0.99 |
One-day post-IIT | |||
Body mass index (kg/m2) | 29.7±4.6 | 30.9±6.7 | 0.62 |
Waist circumference (cm) | 102.1±12.7 | 103.6±14.9 | 0.80 |
Systolic blood pressure (mm Hg) | 120±12 | 120±14 | 0.90 |
Diastolic blood pressure (mm Hg) | 67±13 | 67±9 | 0.89 |
Alanine aminotransferase (IU/L) | 39±26 | 28±11 | 0.18 |
Aspartate aminotransferase (IU/L) | 30 (21–40) | 25 (21–30) | 0.17 |
γ-Glutamyl transferase (IU/L) | 33 (21–42) | 21 (16–31) | 0.19 |
Glycemia | |||
Fasting plasma glucose (mmol/L) | 5.8±0.6 | 5.7±0.4 | 0.66 |
A1c (%) | 6.4±0.4 | 6.0±0.3 | 0.04 |
Insulin sensitivity/resistance | |||
Matsuda index | 5.7 (4.3–11.4) | 7.3 (3.5–10.4) | 0.93 |
HOMA-IR | 3.6 (2.2–4.3) | 2.6 (1.7–6.5) | 0.93 |
Glucagon profile | |||
Fasting glucagon (pg/mL) | 80±29 | 93±25 | 0.22 |
AUCglucagon | 363±81 | 404±106 | 0.29 |
β-Cell function | |||
ISSI-2 | 189 (178–241) | 240 (207–332) | 0.06 |
ΔISR0–120/Δgluc0–120×Matsuda index | 0.16 (0.12–0.24) | 0.23 (0.12–0.46) | 0.12 |
At 48 weeks | |||
Body mass index (kg/m2) | 29.8±4.9 | 30.4±6.6 | 0.81 |
Waist circumference (cm) | 102.1±13.7 | 102.4±14.8 | 0.96 |
Systolic blood pressure (mm Hg) | 118±18 | 123±15 | 0.42 |
Diastolic blood pressure (mm Hg) | 68±9 | 68±11 | 0.81 |
Alanine aminotransferase (IU/L) | 27±10 | 27±9 | 0.84 |
Aspartate aminotransferase (IU/L) | 22 (19–34) | 23 (19–27) | 0.57 |
γ-Glutamyl transferase (IU/L) | 30 (26–47) | 27 (17–36) | 0.19 |
Glycemia | |||
Fasting plasma glucose (mmol/L) | 7.1±0.8 | 5.7±0.6 | <0.001 |
A1c (%) | 7.1±0.6 | 6.0±0.3 | <0.001 |
Non-diabetic OGTT n (%) | 0 (0) | 7 (50) | 0.006 |
Insulin sensitivity/resistance | |||
Matsuda index | 4.3 (3.4–5.8) | 5.8 (3.1–9.8) | 0.47 |
HOMA-IR | 5.4 (4.8–6.8) | 3.5 (2.2–7.5) | 0.16 |
Glucagon profile | |||
Fasting glucagon (pg/mL) | 141±67 | 95±43 | 0.06 |
AUCglucagon | 567±293 | 438±162 | 0.19 |
β-Cell function | |||
ISSI-2 | 140 (100–206) | 257 (206–354) | <0.001 |
ΔISR0–120/Δgluc0–120×Matsuda index | 0.12 (0.05–0.20) | 0.24 (0.14–0.54) | 0.14 |
AUCglucagon, area-under-the-glucagon-curve; HOMA-IR, Homeostasis Model Assessment; ISR, insulin secretion rate, ISSI-2, Insulin Secretion-Sensitivity Index-2; OGTT, oral glucose tolerance test.