Table 1.
Primary and Secondary End Points at 3 Years.*
| End Point | Medical Therapy (N = 40) |
Gastric Bypass (N = 48) |
Sleeve Gastrectomy (N = 49) |
P Value | ||
|---|---|---|---|---|---|---|
| Gastric Bypass vs. Medical Therapy |
Sleeve Gastrectomy vs. Medical Therapy |
Gastric Bypass vs. Sleeve Gastrectomy |
||||
| Glycated hemoglobin | ||||||
| Level — no. of patients (%) | ||||||
| ≤6% | 2 (5) | 18 (38) | 12 (24) | <0.001 | 0.01 | 0.17 |
| ≤6% without diabetes medications | 0 | 17 (35) | 10 (20) | <0.001 | 0.002 | 0.10 |
| ≤6.5% | 7 (18) | 23 (48) | 23 (47) | 0.003 | 0.003 | 0.92 |
| ≤6.5% without diabetes medications | 0 | 22 (46) | 14 (29) | <0.001 | <0.001 | 0.08 |
| ≤7% | 16 (40) | 31 (65) | 32 (65) | 0.02 | 0.02 | 0.94 |
| ≤7% without diabetes medications | 0 | 28 (58) | 16 (33) | <0.001 | <0.001 | 0.01 |
| At baseline — % | 9.0±1.4 | 9.3±1.4 | 9.5±1.7 | |||
| At 3 yr — % | ||||||
| Mean | 8.4±2.2 | 6.7±1.3 | 7.0±1.3 | <0.001 | <0.001 | 0.42 |
| Median (IQR) | 7.7 (6.7 to 9.6) | 6.6 (5.8 to 7.4) | 6.6 (6.1 to 7.5) | |||
| Change from baseline — percentage points | −0.6±2.5 | −2.5±1.9 | −2.5±2.1 | <0.001 | <0.001 | 0.99 |
| Relapse — no./total no. (%)† | ||||||
| Glycemic control | 4/5 (80) | 5/21 (24) | 9/18 (50) | 0.03 | 0.34 | 0.09 |
| Diabetes | NA | 8/21 (38) | 6/13 (46) | NA | NA | 0.64 |
| Median (IQR) fasting plasma glucose — mg/dl | ||||||
| At baseline | 157 (115 to 199) | 193 (142 to 236) | 164 (132 to 224) | |||
| At 3 yr | 132 (104 to 179) | 100 (87 to 141) | 106 (86 to 136) | 0.001 | 0.007 | 0.92 |
| Change from baseline‡ | −6.0 (−68.5 to 56.0) | −85.5 (−122.0 to −21.5) | −46.0 (−113.0 to −21.0) | 0.001 | 0.006 | 0.24 |
| Body weight | ||||||
| At baseline — kg | 104.5±14.2 | 106.8±14.9 | 100.6±16.5 | |||
| At 3 yr — kg | 100.2±16.6 | 80.6±15.5 | 79.3±15.1 | <0.001 | <0.001 | 0.69 |
| Change from baseline — kg | −4.3±8.8 | −26.2±10.6 | −21.3±9.7 | <0.001 | <0.001 | 0.02 |
| % Change from baseline | −4.2±8.3 | −24.5±9.1 | −21.1±8.9 | <0.001 | <0.001 | 0.06 |
| Other risk factors | ||||||
| % Change from baseline in low-density lipoprotein cholesterol | 2.5±29.9 | 16.9±54.5 | 14.5±52.2 | 0.14 | 0.20 | 0.82 |
| % Change from baseline in high-density lipoprotein cholesterol | 4.6±20.7 | 34.7±27.3 | 35.0±31.0 | <0.001 | <0.001 | 0.96 |
| Median % change from baseline in triglycerides (IQR) | −21.5 (−45.4 to 16.4) | −45.9 (−61.0 to −7.5) | −31.5 (−52.1 to −6.9) | 0.01 | 0.01 | 0.18 |
| Change from baseline in blood pressure — mm Hg | ||||||
| Systolic | 0.63±22.63 | 1.29±20.38 | −4.43±20.69 | 0.88 | 0.27 | 0.17 |
| Diastolic | −6.48±12.33 | −4.25±10.57 | −6.27±13.30 | 0.36 | 0.94 | 0.41 |
Plus–minus values are means ±SD. To convert the values for glucose to millimoles per liter, multiply by 0.05551. To convert the values for cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for triglycerides to millimoles per liter, multiply by 0.01129. IQR denotes interquartile range, and NA not applicable.
Relapse of glycemic control was defined as having met the primary end point for glycated hemoglobin of 6% or less at 1 year but not at 3 years. Relapse of diabetes was defined as having met the primary end point for glycated hemoglobin of 6% or less with the use of no antidiabetic medications at 1 year but not at 3 years. None of the patients in the medical-therapy group had a complete remission of diabetes, and thus, these patients were not evaluated for relapse.
For skewed data, the median of the change is not the numerical difference between the group-level median at baseline and the median value at 3 years.