. | Surgical intervention (N = 171) . | Medical/lifestyle intervention (N = 85) . | Difference (95% CI)d . | P value . |
---|---|---|---|---|
Primary end point, n/N (%) | ||||
HbA1c ≤6.5 off diabetes medications | 60/160 (37.5) | 2/76 (2.6) | 34.9 (26.5, 43.1) | <0.001 |
Estimated probability from GLM modelb % (95% CI) | 41.6 (29.6, 58.3) | 1.0 (0.2, 4.0) | <0.001 | |
Secondary end points, n/N (%) | ||||
≤7.0 with or without diabetes medications | 109/171 (63.7) | 28/85 (32.9) | 30.8 (18.5, 43.1) | <0.001 |
≤6.5 with or without diabetes medications | 81/171 (47.4) | 15/85 (17.6) | 29.7 (18.7, 40.7) | <0.001 |
≤6.0 without diabetes medications | 41/160 (25.6) | 2/76 (2.6) | 23.0 (15.3, 30.6) | <0.001 |
HbA1c level (%) | ||||
At 3 years (n = 171, n = 85) | 6.9 ± 1.3 | 8.2 ± 1.9 | ||
Change from baseline | −1.9 ± 2.0 | −0.1 ± 2.0 | −1.9 (−2.4, −1.3) | <0.001 |
Fasting plasma glucose (mg/dL), median (Q1, Q3) | ||||
At 3 years (n = 166, n = 75) | 107 (89, 139) | 129 (97, 170) | ||
Change from baseline | −52 (−105, −5) | −12 (−48, 26) | −40 (−61, −19) | <0.001c |
Body weight (kg) | ||||
At 3 years (n = 161, n = 82) | 80.6 ± 15.5 | 100.0 ± 17.5 | ||
Change from baseline | −22.7 ± 10.5 | −5.0 ± 8.7 | −17.6 (−20.3, −15.0) | <0.001 |
BMI (kg/m2) | ||||
At 3 years (n = 161, n = 82) | 28.4 ± 4.2 | 34.5 ± 4.1 | ||
Change from baseline | −8.0 ± 3.6 | −1.8 ± 2.9 | −6.3 (−7.2, −5.4) | <0.001 |
Waist circumference, cm | ||||
At 3 years (n = 142, n = 67) | 97.4 ± 11.5 | 111.1 ± 13.0 | ||
Change from baseline | −17.5 ± 10.2 | −2.1 ± 9.6 | −15.4 (−18.3, −12.5) | <0.001 |
LDL-C (mg/dL) | ||||
At 3 years (n = 165, n = 80) | 100.2 ± 29.9 | 95.0 ± 35.9 | ||
Change from baseline | 2.2 ± 38.5 | −0.2 ± 26.3 | 2.4 (−7.1, 11.8) | 0.62 |
HDL cholesterol (mg/dL) | ||||
At 3 years (n = 167, n = 83) | 57.2 ± 16.5 | 46.8 ± 12.4 | ||
Change from baseline | 14.5 ± 11.1 | 2.3 ± 10.1 | 12.2 (9.3, 15.0) | <0.001 |
Triglycerides (mg/dL), median (Q1, Q3) | ||||
At 3 years (n = 167, n = 84) | 99 (77, 141) | 124 (93, 160) | ||
Change from baseline | −48 (−110, −2) | −10 (−70, 15) | −37 (−59, −15) | 0.004c |
SBP (mmHg) | ||||
At 3 years (n = 159, n = 83) | 132 ± 18.5 | 133 ± 18.0 | ||
Change from baseline | −2.7 ± 19.3 | 3.2 ± 19.2 | −5.9 (−11.1, −0.7) | 0.03 |
Diastolic blood pressure (mmHg) | ||||
At 3 years (n = 159, n = 83) | 76 ± 9.9 | 76 ± 9.8 | ||
Change from baseline | −4.0 ± 10.1 | −3.0 ± 10.4 | −1.0 (−3.8, 1.7) | 0.45 |
Percentage with HbA1c <7%, SBP <130/80 mmHg, and LDL-C <100 mg/dL | 24/155 (15.5) | 8/77 (10.4) | 5.1 (−3.8, 14.0) | 0.29 |
Metabolic syndrome, n/N (%) | 56/144 (38.9) | 46/67 (68.7) | −29.8 (−43.4, −16.1) | <0.001 |
Albumin-to-creatinine ratio, µg/mg creatinine, median (Q1, Q3) | ||||
At 3 years (n = 127, n = 63) | 5 (3, 10) | 7 (4, 13) | ||
Change from baseline | −2 (−13, 1) | 0 (−4, 4) | −2 (−4, 0) | 0.003c |
CKD-EPI eGFR (mL/min/1.73 m2) | ||||
At 3 years (n = 166, n = 84) | 99.6 ± 18.3 | 98.7 ± 20.9 | ||
Change from baseline | −4.6 ± 17.3 | −5.6 ± 17.5 | 1.0 (−3.8, 5.7) | 0.55 |
. | Surgical intervention (N = 171) . | Medical/lifestyle intervention (N = 85) . | Difference (95% CI)d . | P value . |
---|---|---|---|---|
Primary end point, n/N (%) | ||||
HbA1c ≤6.5 off diabetes medications | 60/160 (37.5) | 2/76 (2.6) | 34.9 (26.5, 43.1) | <0.001 |
Estimated probability from GLM modelb % (95% CI) | 41.6 (29.6, 58.3) | 1.0 (0.2, 4.0) | <0.001 | |
Secondary end points, n/N (%) | ||||
≤7.0 with or without diabetes medications | 109/171 (63.7) | 28/85 (32.9) | 30.8 (18.5, 43.1) | <0.001 |
≤6.5 with or without diabetes medications | 81/171 (47.4) | 15/85 (17.6) | 29.7 (18.7, 40.7) | <0.001 |
≤6.0 without diabetes medications | 41/160 (25.6) | 2/76 (2.6) | 23.0 (15.3, 30.6) | <0.001 |
HbA1c level (%) | ||||
At 3 years (n = 171, n = 85) | 6.9 ± 1.3 | 8.2 ± 1.9 | ||
Change from baseline | −1.9 ± 2.0 | −0.1 ± 2.0 | −1.9 (−2.4, −1.3) | <0.001 |
Fasting plasma glucose (mg/dL), median (Q1, Q3) | ||||
At 3 years (n = 166, n = 75) | 107 (89, 139) | 129 (97, 170) | ||
Change from baseline | −52 (−105, −5) | −12 (−48, 26) | −40 (−61, −19) | <0.001c |
Body weight (kg) | ||||
At 3 years (n = 161, n = 82) | 80.6 ± 15.5 | 100.0 ± 17.5 | ||
Change from baseline | −22.7 ± 10.5 | −5.0 ± 8.7 | −17.6 (−20.3, −15.0) | <0.001 |
BMI (kg/m2) | ||||
At 3 years (n = 161, n = 82) | 28.4 ± 4.2 | 34.5 ± 4.1 | ||
Change from baseline | −8.0 ± 3.6 | −1.8 ± 2.9 | −6.3 (−7.2, −5.4) | <0.001 |
Waist circumference, cm | ||||
At 3 years (n = 142, n = 67) | 97.4 ± 11.5 | 111.1 ± 13.0 | ||
Change from baseline | −17.5 ± 10.2 | −2.1 ± 9.6 | −15.4 (−18.3, −12.5) | <0.001 |
LDL-C (mg/dL) | ||||
At 3 years (n = 165, n = 80) | 100.2 ± 29.9 | 95.0 ± 35.9 | ||
Change from baseline | 2.2 ± 38.5 | −0.2 ± 26.3 | 2.4 (−7.1, 11.8) | 0.62 |
HDL cholesterol (mg/dL) | ||||
At 3 years (n = 167, n = 83) | 57.2 ± 16.5 | 46.8 ± 12.4 | ||
Change from baseline | 14.5 ± 11.1 | 2.3 ± 10.1 | 12.2 (9.3, 15.0) | <0.001 |
Triglycerides (mg/dL), median (Q1, Q3) | ||||
At 3 years (n = 167, n = 84) | 99 (77, 141) | 124 (93, 160) | ||
Change from baseline | −48 (−110, −2) | −10 (−70, 15) | −37 (−59, −15) | 0.004c |
SBP (mmHg) | ||||
At 3 years (n = 159, n = 83) | 132 ± 18.5 | 133 ± 18.0 | ||
Change from baseline | −2.7 ± 19.3 | 3.2 ± 19.2 | −5.9 (−11.1, −0.7) | 0.03 |
Diastolic blood pressure (mmHg) | ||||
At 3 years (n = 159, n = 83) | 76 ± 9.9 | 76 ± 9.8 | ||
Change from baseline | −4.0 ± 10.1 | −3.0 ± 10.4 | −1.0 (−3.8, 1.7) | 0.45 |
Percentage with HbA1c <7%, SBP <130/80 mmHg, and LDL-C <100 mg/dL | 24/155 (15.5) | 8/77 (10.4) | 5.1 (−3.8, 14.0) | 0.29 |
Metabolic syndrome, n/N (%) | 56/144 (38.9) | 46/67 (68.7) | −29.8 (−43.4, −16.1) | <0.001 |
Albumin-to-creatinine ratio, µg/mg creatinine, median (Q1, Q3) | ||||
At 3 years (n = 127, n = 63) | 5 (3, 10) | 7 (4, 13) | ||
Change from baseline | −2 (−13, 1) | 0 (−4, 4) | −2 (−4, 0) | 0.003c |
CKD-EPI eGFR (mL/min/1.73 m2) | ||||
At 3 years (n = 166, n = 84) | 99.6 ± 18.3 | 98.7 ± 20.9 | ||
Change from baseline | −4.6 ± 17.3 | −5.6 ± 17.5 | 1.0 (−3.8, 5.7) | 0.55 |
Estimated glomerular filtration rate (eGFR) according to CKD-EPI equation (2009): GFR = 141 × min (Scr/κ, 1)α × max(Scr/κ, 1) − 1.209 × 0.993Age × 1.018 [if female] × 1.159 [if Black]; where Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is −0.329 for females and −0.411 for males; min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; GLM, generalized linear model; LDL-C, LDL cholesterol; SBP, systolic blood pressure.
Population includes patients with nonmissing HbA1c at 3 years.
Probability of meeting end point definition derived from a GLM using an inverse link function including covariates for baseline HbA1c, insulin use, sex, and duration of diabetes.
Wilcoxon rank sum test.
Risk differences and exact 95% CIs are displayed for binary variables, mean differences and 95% CIs generated by ANOVA are presented for continuous variables with a normal distribution, and median differences with 95% CIs calculated using quantile regression are presented for continuous data with a nonnormal distribution.