Table 2.
Effects of Growth Hormone vs Placebo on Body Composition, Lipid Profiles, Biochemical Parameters, and Cardiovascular and Immune Functiona
| Growth Hormone |
Placebo |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (95% CI) |
Aggregate Change, Mean (SEM) | Mean (95% CI) |
Aggregate Change, Mean (SEM) | Treatment Effect (95% CI) | ||||||||
| Baseline (n = 25) | Month 6 (n = 25) | Month 12 (n = 23) | Month 18 (n = 21) | Baseline (n = 27) | Month 6 (n = 27) | Month 12 (n = 27) | Month 18 (n = 27) | P Valueb | ||||
| Body Composition | ||||||||||||
| VAT, cm2 | 241 (201-281) |
217 (180-254) |
220 (173-266) |
223 (182-263)c |
-22 (6) | 204 (172-236) |
200 (167-233) |
195 (165-226) |
203 (169-238) |
-4 (4) | -19 (-38 to -0.5) |
.049 |
| SAT, cm2 | 183 (140-225)c |
190 (144-236)c |
190 (142-238) |
177 (120-233)c |
4 (4) | 196 (144-248) |
200 (141-259) |
197 (137-257) |
203 (138-267) |
4(4) | 1 (-14 to 16) |
.89 |
| Trunk fat, kg | 14.5 (12.3-16.6) |
13.9 (11.5-16.3) |
13.4 (11.1-15.6) |
13.1 (10.7-15.6) |
-0.5 (0.2) | 12.9 (10.8-14.9) |
13.2 (11.0-15.4) |
12.9 (10.6-15.2)c |
13.1 (10.8-15.4) |
0.2 (0.2) | -0.8 (-1.5 to -0.04) |
.04 |
| Extremity fat, kg | 7.4 (5.9-8.9) |
7.6 (6.0-9.2) |
7.5 (6.2-8.8) |
7.2 (5.7-8.7) |
0.3 (0.1) |
6.7 (4.9-8.5) |
6.9 (5.0-8.9) |
7.0 (4.9-9.2)c |
7.2 (5.1-9.3) |
0.3 (0.1) | 0 (-0.4 to 0.4) |
.94 |
| Trunk-to-lower extremity fat ratio | 3.8 (3.2-4.4) |
3.5 (3.0-4.0) |
3.3 (2.8-3.7) |
3.5 (2.9-4.0) |
-0.4 (0.1) | 3.7 (3.3-4.1) |
3.7 (3.3-4.2) |
3.7 (3.3-4.2)c |
3.7 (3.3-4.2) |
0 (0) | -0.4 (-0.6 to -0.2) |
<.001 |
| Lean mass, kg | 66.4 (62.4-70.5) |
67.7 (63.3-72.0) |
66.5 (61.9-71.1) |
65.8 (60.7-70.9) |
0.8 (0.3) | 66.8 (64.0-69.6) |
66.4 (63.5-69.3) |
66.6 (63.6-69.6)c |
66.2 (63.2-69.3) |
-0.5 (0.3) | 1.3 (0.2 to 2.3) |
.02 |
| BMI | 29.2 (27.5-31.0) |
29.5 (27.6-31.5) |
29.1 (27.4-30.7) |
28.5 (26.7-30.4) |
0.2 (0.2) | 28.1 (26.5-29.8) |
28.3 (26.4-30.2)c |
28.3 (26.3-30.2) |
28.3 (26.4-30.3) |
0.1 (0.1) | 0.1 (-0.4 to 0.6) |
.67 |
| Lipid Levels | ||||||||||||
| Triglycerides, mg/dL | 183 (142-244) |
169 (137-238) |
169 (131-234)c |
186 (121-219) |
-7 (-43 to 41) | 204 (156-317) |
215 (168-362) |
197 (154-333)c |
243 (164-308)c |
0 (-56 to 51) |
-7a | .002 |
| HDL cholesterol, mg/dL | 40 (36-44) |
43 (38-47) |
44 (39-49)c |
43 (40-47) |
4 (1) | 39 (35-43) |
41 (37-44) |
43 (38-47)c |
43 (39-48)c |
3(1) | 1 (-2 to 5) | .46 |
| Total cholesterol, mg/dL | 189 (172-207) |
191 (173-209) |
184 (169-199)c |
183 (165-201) |
-1 (3) | 194 (178-209) |
189 (171-207) |
184 (167-201)c |
189 (172-206)c |
-6 (4) | 3 (-11 to 17) | .64 |
| Biochemical Parameters | ||||||||||||
| IGF-1, ng/mL | 146 (122-170) |
260 (227-292) |
267 (220-314) |
236 (195-278)c |
109 (11) | 159 (136-182) |
145 (128-161)c |
133 (118-149)c |
125 (110-139) |
-25 (8) | 129 (95 to 164) |
<.001 |
| Fasting blood glucose, mg/dL | 94 (89-100)c |
99 (92-106) |
101 (93-109) |
102 (93-110) |
6 (1) | 89 (85-93) |
92 (89-95) |
94 (90-99) |
96 (92-99) |
5 (1) | 2 (-3 to 7) | .39 |
| 2-h glucose, mg/dL | 138 (121-156)c |
156 (130-181)c |
155 (129-181) |
158 (132-184) |
16 (5) | 137 (121-153) |
132 (120-144) |
130 (112-148) |
136 (117-155)c |
-4 (4) | 22 (6 to 37) | .009 |
| Fasting insulin, μIU/mL | 14 (10-18) |
14 (9-19)c |
15 (11-18) |
14 (8-19) |
0 (1) | 10 (6-14) |
13 (8-18) |
23 (-1 to 47) |
11 (8-14)c |
6 (4) | -5 (-19 to 10) |
.51 |
| Hemoglobin A1c,% | 5.5 (5.3-5.6)c |
5.6 (5.4-5.9) |
5.7 (5.4-6.0) |
5.7 (5.4-5.9) |
0.2 (0.1) | 5.3 (5.1-5.5) |
5.4 (5.2-5.6) |
5.5 (5.3-5.7) |
5.6 (5.3-6.0) |
0.2 (0.1) | 0.1 (-0.1 to 0.2) | .47 |
| Adiponectin, μg/mL | 4.4 (3.3-5.5) |
5.6 (4.1-7.1)c |
5.2 (4.3-6.0) |
5.1 (4.3-5.8) |
1.0 (0.3) | 4.0 (3.0-5.0) |
4.4 (3.2-5.6) |
4.6 (3.3-5.8) |
4.7 (3.5-5.8)c |
0.5 (0.1) | 0.5 (-0.4 to 1.4) | .27 |
| Cardiovascular Parameters | ||||||||||||
| Carotid IMT, mm | 0.763 (0.719-0.806) |
0.777 (0.717-0.838) |
0.751 (0.689-0.813)c |
0.754 (0.683-0.824)c |
0.003 (0.008) | 0.725 (0.683-0.766) |
0.739 (0.695-0.783)c |
0.715 (0.672-0.759) |
0.717 (0.672-0.762)c |
-0.003 (0.009) | -0.004 (-0.035 to 0.026) | .78 |
| Systolic BP, mm Hg | 129 (121-138) |
126 (119-132) |
125 (118-131) |
121 (114-128) |
-5 (2) | 121 (116-127) |
122 (116-127) |
122 (118-126) |
124 (118-130) |
1 (2) | -6 (-13 to 1) | .09 |
| Diastolic BP, mm Hg | 80 (77-84) |
79 (75-82) |
79 (75-82) |
76 (72-80) |
-3 (1) | 72 (68-76) |
75 (72-78) |
77 (74-80) |
76 (73-80) |
4 (1) | -7 (-11 to -2) | .006 |
| Immune Function | ||||||||||||
| CD4 cells/μL | 579 (459-699)d |
552 (454-651)c |
579 (470-687) |
532 (440-625) |
-19 (13) | 661 (539-784) |
690 (519-861) |
647 (525-769)c |
675 (511-840)c |
15 (21) | -30 (-97 to 37) | .38 |
| Viral load [log10 (copies of RNA/mL)] | 2.8 (2.6-3.0) | NA | NA | 2.8 (2.6-3.0) | 0 (0.1) | 2.8 (2.5-3.0) | NA | NA | 2.8 (2.5-3.1) | 0 (0.2) | 0 (-0.4 to 0.3) | .91 |
| Quality of life score (MOS-HIV)e | 66 (58-75) | 68 (59-78) | 62 (51-73) | 59 (46-72) | -4 (3) | 64 (56-72) | 61 (54-68) | 57 (49-66) | 63 (56-69) | -4 (3) | 1 (-9 to 12) | .78 |
Abbreviations: BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; BP, blood pressure; CI, confidence interval; HDL, high-density lipoprotein; HIV, human immunodeficiency virus; IGF-1, insulinlike growth factor 1; IMT, intima-media thickness; MOS-HIV, Medical Outcomes Study HIV Health Survey; NA, not applicable; SAT, subcutaneous adipose tissue; VAT, visceral adipose tissue.
SI conversions: To convert triglycerides to mmol/L, multiply by 0.0113; to convert total and HDL cholesterol to mmol/L, multiply by 0.0259; to convert IGF-1 to nmol/L, multiply by 0.131; to convert glucose to mmol/L, multiply by 0.0555; to convert insulin to pmol/L, multiply by 6.945.
Baseline results are reported for all participants for whom at least 1 follow-up result was obtained. Treatment effects are reported as net difference between the change in growth hormone and placebo. For triglycerides, results are reported as median (interquartile range) using the Wilcoxon rank sum test. The 95% CI could not be calculated for triglycerides given the use of a nonparametric analysis. All baseline comparisons are P > .05 by t test (analysis of variance), except for diastolic BP.
Aggregate change over 18 months for growth hormone vs placebo. See the “Statistical Analysis” section for description of statistical methods used.
Number of patients analyzed was 1 less than the total number (ie, n = 20 for VAT with growth hormone at month 18).
n = 23.
Scale of 0 to 100, with higher number indicating better quality of life. For growth hormone group, n = 23 at baseline and month 6; n = 19 at month 12; n = 17 at month 18; and for placebo group, n = 25 at baseline and month 6; and n = 24 at months 12 and 18.