Table 1.
Demographic, clinical, and laboratory data in the study subjects
| Baseline* |
1 year |
2 years |
3 years |
P | |||||
|---|---|---|---|---|---|---|---|---|---|
| RYGB | IMWM | RYGB | IMWM | RYGB | IMWM | RYGB | IMWM | ||
| N | 19 | 19 | |||||||
| Age, years | 50.7 ± 7.6 | 52.6 ± 4.3 | |||||||
| Sex | |||||||||
| Male | 6 (32) | 9 (47) | |||||||
| Female | 13 (68) | 10 (53) | |||||||
| Race/ethnicity | |||||||||
| White | 14 (74) | 10 (53) | |||||||
| African American | 3 (16) | 8 (42) | |||||||
| Asian | 1 (5) | 0 (0) | |||||||
| Hispanica | 1 (5) | 1 (5) | |||||||
| BMI <35 kg/m2 | 6 (32) | 7 (37) | |||||||
| Duration of diabetes, years | 10.6 ± 6.6 | 10.2 ± 6.1 | |||||||
| Clinical end points, n (%)b |
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| Study-defined diabetes resolutionc | 11 (58) | 3 (16) | 7 (37) | 0 (0) | 8 (42) | 0 (0) | 0.005 | ||
| Meeting ADA treatment goals | |||||||||
| HbA1c <7.0% (<53 mmol/mol) | 15 (79) | 5 (26) | 13 (68) | 5 (26) | 11 (58) | 2 (11) | 0.011 | ||
| Direct LDL cholesterol <100 mg/dL | 15 (79) | 9 (47) | 10 (53) | 8 (42) | 8 (42) | 6 (32) | 0.300 | ||
| Systolic blood pressure <130 mmHg | 16 (84) | 11 (58) | 14 (74) | 5 (26) | 8 (42) | 6 (32) | 0.300 | ||
| Meeting all three goals | 11 (58) | 1 (5) | 7 (37) | 3 (16) | 2 (11) | 1 (5) | 0.293 | ||
| Normoglycemia | |||||||||
| HbA1c <6.0% (<42 mmol/mol) | 6 (32) | 0 (0) | 4 (21) | 0 (0) | 2 (11) | 0 (0) | 0.104 | ||
| Fasting plasma glucose <100 mg/dL | 14 (74) | 3 (16) | 8 (42) | 2 (11) | 7 (37) | 3 (16) | 0.216 | ||
| Meeting both criteria | 6 (32) | 0 (0) | 3 (16) | 0 (0) | 1 (5) | 0 (0) | 0.184 | ||
| Changes in clinical, metabolic, and laboratory measures, mean (95% CI)d |
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| Medications | |||||||||
| Antidiabetes | 2.3 ± 1.0 | 1.8 ± 0.8 | −1.6 (−2.0, −1.3) | 0.1 (−0.3, 0.4) | −1.4 (−1.8, −1.1) | 0.4 (0.0, 0.8) | −1.4 (−1.9, −1.0) | 0.7 (0.2, 1.2) | <0.001 |
| Antihypertensive | 1.6 ± 1.0 | 1.2 ± 1.0 | −0.8 (−1.2, −0.5) | 0.0 (−0.4, 0.3) | −1.0 (−1.3, −0.6) | 0.0 (−0.4, 0.4) | −0.9 (−1.3, −0.5) | 0.2 (−0.2, 0.7) | <0.001 |
| Lipid lowering | 0.9 ± 0.5 | 0.8 ± 0.5 | −0.6 (−0.8, −0.3) | 0.2 (0.0, 0.4) | −0.4 (−0.7, −0.2) | 0.0 (−0.3, 0.2) | −0.5 (−0.8, −0.3) | 0.0 (−0.2, 0.3) | <0.001e |
| Weight, kg | 104.6 ± 15.5 | 102.7 ± 17.0 | −27.9 (−30.2, −25.6) | −6.9 (−9.3, −4.6) | −26.3 (−29.6, −22.9) | −4.8 (−8.6, −1.0) | −24.9 (−29.5, −20.4) | −5.2 (−10.3, −0.2) | <0.001e |
| BMI, kg/m2 | 36.0 ± 3.5 | 36.5 ± 3.4 | −9.7 (−10.5, −8.8) | −2.3 (−3.1, −1.4) | −9.2 (−10.3, −8.0) | −1.6 (−2.9, −0.2) | −8.7 (−10.3, −7.1) | −1.8 (−3.5, 0.0) | <0.001e |
| Body composition | |||||||||
| Fat mass, kg | 45.5 ± 9.4 | 42.6 ± 9.8 | −22.6 (−25.0, −20.2) | −6.0 (−8.6, −3.4) | −21.4 (−24.6, −18.2) | −3.0 (−6.7, 0.7) | −19.9 (−24.0, −15.8) | −4.1 (−8.8, 0.6) | <0.001e |
| Lean mass, kg | 59.2 ± 14.1 | 60.1 ± 10.8 | −5.2 (−6.7, −3.6) | −1.3 (−2.9, 0.3) | −5.2 (−6.9, −3.5) | −1.9 (−3.8, 0.1) | −5.8 (−7.8, −3.8) | −1.3 (−3.5, 1.0) | 0.003e |
| Waist circumference, cm | 117.8 ± 14.9 | 114.1 ± 12.2 | −26.9 (−30.5, −23.4) | −6.4 (−10.1, −2.6) | −27.4 (−32.1, −22.6) | −5.4 (−10.9, 0.1) | −24.8 (−31.0, −18.6) | −1.0 (−8.2, 6.2) | <0.001e |
| Blood pressure | |||||||||
| Systolic, mmHg | 132.8 ± 10.5 | 126.3 ± 14.7 | −13.1 (−19.0, −7.1) | −1.6 (−7.9, 4.8) | −10.7 (−17.5, −3.8) | 4.2 (−4.1, 12.4) | −0.3 (−8.3, 7.8) | 9.7 (0.3, 19.1) | 0.011 |
| Diastolic, mmHg | 81.7 ± 7.4 | 76.6 ± 8.8 | −5.3 (−8.6, −2.0) | −2.4 (−5.9, 1.1) | −4.3 (−7.8, −0.7) | 0.6 (−3.7, 4.9) | 2.0 (−2.0, 5.9) | −1.2 (−5.8, 3.5) | <0.001f |
| Physical fitness | |||||||||
| Distance walked in 6 min, m | 464 ± 56 | 467 ± 56 | 13 (−11, 37) | 25 (0, 50) | 34 (5, 62) | 32 (−1, 65) | 33 (−1, 68) | 37 (−4, 79) | 0.548 |
| Heart rate recovery at 1 min, bpm | 92.2 ± 15.2 | 87.5 ± 12.0 | −10.7 (−15.4, −6.1) | 0.9 (−4.0, 5.9) | −5.7 (−11.3, −0.2) | 2.7 (−4.0, 9.4) | −7.0 (−13.6, −0.4) | 1.4 (−6.9, 9.7) | 0.002 |
| 10-year UKPDS risk scores | |||||||||
| CHD, % | 9.8 ± 9.6 | 10.8 ± 6.9 | −4.1 (−5.7, −2.5) | 0.5 (−1.1, 2.0) | −2.6 (−4.3, −0.8) | −0.7 (−2.6, 1.2) | −2.5 (−4.3, −0.7) | 0.1 (−2.0, 2.1) | 0.009e |
| Fatal CHD, % | 6.5 ± 7.7 | 6.9 ± 4.9 | −3.0 (−4.3, −1.7) | 0.4 (−0.9, 1.8) | −1.8 (−3.3, −0.3) | 0.1 (−1.5, 1.7) | −1.5 (−3.2, 0.2) | 1.1 (−0.8, 2.9) | 0.012 |
| Stroke, % | 4.0 ± 4.1 | 4.0 ± 2.3 | −0.2 (−0.6, 0.2) | 0.6 (0.2, 1.0) | 0.6 (0.1, 1.1) | 1.2 (0.6, 1.8) | 1.4 (0.8, 2.0) | 2.2 (1.5, 2.9) | 0.024 |
| Fatal stroke, % | 0.6 ± 0.6 | 0.5 ± 0.3 | −0.1 (−0.2, 0.0) | 0.1 (0.0, 0.2) | 0.0 (−0.2, 0.1) | 0.2 (0.0, 0.4) | 0.2 (0.0, 0.3) | 0.5 (0.3, 0.7) | 0.004 |
| Laboratory measurements | |||||||||
| HbA1c, % | 8.24 ± 1.42 | 8.78 ± 1.02 | −1.97 (−2.52, −1.41) | −0.09 (−0.66, 0.47) | −1.91 (−2.49, −1.33) | −0.32 (−0.99, 0.35) | −1.79 (−2.38, −1.20) | −0.39 (−1.06, 0.28) | <0.001e |
| HbA1c, mmol/mol | 66.6 ± 15.5 | 72.5 ± 11.1 | −21.5 (−27.5, −15.4) | −1.0 (−7.2, 5.1) | −20.9 (−27.2, −14.5) | −3.5 (−10.8, 3.8) | −19.6 (−26.0, −13.1) | −4.3 (−11.6, 3.1) | <0.001e |
| Fasting plasma glucose, mg/dL | 132 ± 50 | 162 ± 54 | −47 (−62, −32) | −3 (−19, 13) | −47 (−64, −31) | −11 (−30, 8) | −46 (−62, −29) | −9 (−29, 10) | <0.001e |
| Total cholesterol, mg/dL | 154 ± 34 | 162 ± 39 | −4 (−18, 10) | 7 (−7, 22) | 7 (−8, 24) | −16 (−35, 3) | 5 (−12, 33) | −12 (−33, 9) | 0.022f |
| Direct LDL cholesterol, mg/dL | 88 ± 28 | 99 ± 29 | −6 (−18, 6) | 9 (−4, 21) | 5 (−9, 19) | −15 (−32, 2) | 3 (−13, 19) | −11 (−30, 8) | 0.037f |
| HDL cholesterol, mg/dL | 44 ± 10 | 39 ± 10 | 10 (7, 13) | 0 (−3, 4) | 12 (7, 16) | −1 (−6, 5) | 15 (10, 21) | 2 (−4, 9) | <0.001e |
| Triglycerides, mg/dL | 120 ± 66 | 156 ± 76 | −46 (−61, −30) | −6 (−23, 10) | −42 (−58, −25) | 6 (−13, 26) | −39 (−55, −22) | −22 (−42, −2) | <0.001e |
| Creatinine, mg/dL | 0.71 ± 0.14 | 0.86 ± 0.21 | −0.06 (−0.10, −0.02) | 0.00 (−0.04, 0.04) | −0.06 (−0.11, −0.01) | 0.07 (0.01, 0.13) | 0.03 (−0.03, 0.10) | 0.05 (−0.02, 0.12) | 0.011e |
| Urine albumin/creatinine, μg/mgg | 3 (0–7) | 3 (0–10) | 4 (2–7) | 3.5 (0–4) | 5 (2.5–15) | 6.5 (4–17) | 6 (3–9) | 6.5 (0–8) | 0.873h |
| Hematocrit, % | 36.8 ± 3.3 | 40.2 ± 4.3 | −2.4 (−3.6, −1.2) | 0.4 (−0.9, 1.6) | −3.0 (−4.4, −1.7) | 1.3 (−0.4, 2.9) | −2.6 (−4.2, −1.0) | 1.0 (−0.8, 2.9) | <0.001 |
| White blood count, ×106/mL | 6.8 ± 2.1 | 6.5 ± 1.8 | −0.9 (−1.4, −0.4) | 0.1 (−0.5, 0.6) | −1.1 (−1.7, −0.5) | 0.1 (−0.6, 0.9) | −0.9 (−1.6, −0.2) | 0.4 (−0.4, 1.2) | <0.001 |
| ALT, IU/L | 32 ± 16 | 27 ± 12 | −10 (−14, −7) | −5 (−9, −1) | −13 (−18, −9) | −9 (−14, −4) | −15 (−19, −10) | −7 (−12, −1) | 0.023 |
| AST, IU/L | 31 ± 22 | 23 ± 13 | −6 (−9, −2) | −4 (−7, 0) | −7 (−11, −4) | −8 (−12, −4) | −8 (−12, −5) | −6 (−11, −2) | 0.767 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
*Baseline data are mean ± SD, n (%), or median (interquartile range), unless otherwise stated.
aHispanic subjects may be any race.
bP values represent comparison of proportions at 3 years (RYGB vs. IMWM) by Fisher exact test.
cPrimary end point, defined as proportion with HbA1c <6.5% and fasting plasma glucose <126 mg/dL with or without antidiabetes medication.
dP values represent differences between groups (RYGB vs. IMWM) from linear mixed-effects model adjusted for baseline values, unless otherwise noted.
eGroup × time interaction also significant at P < 0.05.
fP value represents group × time interaction; group effect was not significant.
gMedian and interquartile range provided due to skewed distribution.
hBy Kruskal-Wallis test for nonparametric data.