Table 1.

Primary and Secondary End Points at 5 Years.^*

End Point	Study Group			P Value†
	Medical Therapy (N = 38)	Gastric Bypass (N = 49)	Sleeve Gastrectomy (N = 47)	Gastric Bypass vs. Medical Therapy	Sleeve Gastrectomy vs. Medical Therapy	Gastric Bypass vs. Sleeve Gastrectomy
Primary end point
Glycated hemoglobin ≤6.0%
In analysis of patients who completed the trial — no. of patients (%)	2 (5.3)‡	14 (28.6)	11 (23.4)	0.01 (unadjusted); 0.03 (adjusted)	0.03 (unadjusted); 0.07 (adjusted)	0.53 (unadjusted); 0.53 (adjusted)
Estimated rate from imputed analysis — %§	7.3	26.4	20.4	0.08	0.17	0.48
Secondary end points
Glycated hemoglobin — no. of patients (%)
≤6.0% without diabetes medications	0	11 (22.4)	7 (14.9)	0.006¶	0.04¶	0.34
≤6.5%	6 (15.8)	19 (38.8)	17 (36.2)	0.06	0.06	0.79
≤6.5% without diabetes medications	0	15 (30.6)	11 (23.4)	0.0033	0.0023	0.43
≤7.0%	8 (21.1)	25 (51.0)	23 (48.9)	0.012	0.016	0.84
Glycated hemoglobin level — %
At baseline	8.8±1.1	9.3±1.4	9.5±1.7
At 5 yr	8.5±2.2	7.3±1.5	7.4±1.6
Change from baseline	−0.3±2.0	−2.1±1.8	−2.1±2.3	0.003	0.003	0.67
Median fasting plasma glucose (IQR) — mg/dl
At baseline	157 (120 to 193)	196 (143 to 231)	164 (129 to 229)
At 5 yr	129 (97 to 172)	110 (92 to 150)	111 (93 to 141)
Change from baseline||	−14 (−60 to 23)	−72 (−114 to −29)	−49 (−120 to −4)	0.003	0.02	0.35
Body weight — kg
At baseline	105.0±14.4	106.8±14.9	100.4±16.8
At 5 yr	99.0±17.0	83.4±15.3	81.9±15.0
Change from baseline	−5.3±10.8	−23.2±9.6	−18.6±7.5	0.003	0.003	0.01
LDL cholesterol — mg/dl
At baseline	100.9±36.8	91.4±28.9	105.7±40.2
At 5 yr	95.8±41.9	93.3±35.5	115.1±42.4
% Change from baseline to 5 yr||	3.7±55.3	12.4±53.8	16.6±48.6	0.99	0.84	0.99
HDL cholesterol — mg/dl
At baseline	48.7±12.8	45.8±13.2	44.3±12.1
At 5 yr	50.4±12.4	60.0±20.2	57.0±16.6
% Change from baseline to 5 yr||	7.0±44.5	31.9±29.1	29.6±29.5	0.012	0.016	0.75
Median triglycerides (IQR) — mg/dl
At baseline	166 (97 to 235)	171 (125 to 257)	160 (119 to 214)
At 5 yr	118 (85 to 169)	114 (81 to 165)	108 (81 to 123)
% Change from baseline to 5 yr||	−8.3 (−37.9 to 22.2)	−39.8 (−58.4 to 7.1)	−29.4 (−51.4 to −2.9)	0.03	0.04	0.47
Systolic blood pressure — mm Hg
At baseline	135.6±17.7	134.7±18.9	136.7±17.9
At 5 yr	131.5±14.55	131.4±18.77	128.3±11.60
Change from baseline to 5 yr	−4.0±20.1	−3.3±22.8	−8.3±20.4	0.88	0.78	0.78
Diastolic blood pressure — mm Hg
At baseline	82.0±11.4	81.8±10.2	82.2±11.7
At 5 yr	77.62±9.83	75.98±11.57	74.11±11.49
Change from baseline to 5 yr	−4.2±11.4	−5.8±12.6	−8.1±14.7	0.86	0.57	0.86

^*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. HDL denotes high-density lipoprotein, IQR interquartile range, and LDL low-density lipoprotein.

^†P values for the primary end point in the analysis of patients who completed the trial are shown as unadjusted and as adjusted for multiple comparisons with the use of the Bonferroni step-down procedure. All P values for the secondary end points were adjusted for multiple comparisons.

^‡One patient in the medical-therapy group crossed over to the gastric-bypass group during year 3 owing to the failure of the patient’s medical therapy and is counted in the denominator of the medical-therapy group.

^§The imputed intention-to-treat population comprised all 150 patients who underwent randomization (50 per group).

^¶Values were compared with the use of Fisher’s exact test.

^||Because of the variability and skewness of the data, the change from baseline or the percent change from baseline is not the numerical difference between the group-level value at baseline and the value at 5 years.