Table 2.
Changes in the metabolic end points by study arm
| NucleomaxX® (n=26) | TDF switch (n=24) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline | Change to week 48a |
P-value | Baseline | Change to week 48a |
P-value | Between-group P-value |
|
| Body mass index, kg/m2 | 26 (19–28) | 0 (−0.4–0.5) | 0.71 | 26 (22–28) | 0 (−0.6–0.7) | 0.70 | 0.53 |
| Limb fat, kg | 4.4 (2.9–6.3) | 0.1 (−0.03–0.3) | 0.65 | 5.5 (3.4–7.0) | 0.4 (−0.06–1.2) | 0.007 | 0.04 |
| Trunk fat, kg | 7.9 (5.6–11.6) | 0.2 (−0.5–0.6) | 0.97 | 7.7 (5.8–10.1) | 0.7 (−0.04–1.4) | 0.02 | 0.02 |
| Fat mtDNA, copies/cell | 662 (395–1,410) | −169 (−778–64) | 0.03 | 641 (396–1,343) | 321 (−298–669) | 0.37 | 0.02 |
| PBMC mtDNA, copies/cell | 301 (253–424) | −24 (−158–91) | 0.44 | 290 (225–381) | −52 (−105–108) | 0.63 | 0.81 |
| ND1/L13 | 2.7 (2.0–8.9) | 3.7 (−0.2–8.0) | 0.001 | 6.3 (3.1–11.4) | 6.3 (3.7–10.9) | <0.001 | 0.07 |
| ND6/L13 | 0.8 (0.5–2.0) | 2.2 (0.2–5.0) | <0.001 | 1.5 (0.8–4.0) | 3.9 (1.6–6.4) | <0.001 | 0.17 |
| CYTB/L13 | 2.2 (1.3–4.0) | 2.8 (0.8–4.5) | <0.001 | 4.7 (2.0–7.1) | 7.1 (3.9–10.1) | <0.001 | 0.01 |
| Lumbar spine BMD, g/cm2 | 1.1 (0.9–1.2) | 0.39% (−0.96–1.68) | 0.52 | 1.05 (1.0–1.1) | 0.0% (−2.9–1.76) | 0.50 | 0.28 |
| Hip BMD, g/cm2 | 0.81 (0.73–0.97) | 0.45% (−0.27–3.56) | 0.14 | 0.81 (0.74–0.94) | −3.3% (−5.1–0.0) | 0.01 | 0.002 |
| IL−6, pg/ml | 2.6 (2.0–3.8) | 26.0 (10.6–53.7) | <0.001 | 4.2 (2.0–14.2) | 2.4 (−1.7–55.0) | 0.21 | 0.02 |
| hsCRP, mg/l | 2.0 (0.8–4.5) | 15.9 (4.5–29.9) | <0.001 | 3.6 (1.4–8.4) | −1.1 (−4.3–7.1) | 0.69 | 0.02 |
| sTNFRI, pg/ml | 590 (536–831) | 48 (−137–274) | 0.27 | 615 (509–894) | 66 (−195–169) | 0.95 | 0.63 |
| sTNFRII, pg/ml | 214 (139–411) | 724 (371–1,091) | <0.001 | 344 (133–723) | 189 (−223–1,355) | 0.10 | 0.18 |
| sVCAM1, ng/ml | 450 (305–611) | 1,986 (912–2,805) | <0.001 | 731 (420–1,769) | 521 (−164–1,991) | 0.11 | 0.04 |
| LDL cholesterol, mg/dl | 123 (96–148) | −2 (−16–11) | 0.43 | 111 (90–127) | −5 (−19–20) | 0.98 | 0.78 |
| Triglycerides, mg/dl | 163 (109–241) | 17 (−34–42) | 0.65 | 187 (132–363) | −38 (−125–32) | 0.05 | 0.07 |
| Glucose, mg/dl | 86 (83–91) | 4 (−3–6) | 0.40 | 85 (78.5–94) | 0 (−6–12) | 0.32 | 0.90 |
| Insulin, mIU/l | 10 (7–16) | 1 (−4–3) | 0.60 | 10 (4–12) | −0.5 (−3.5–3) | 0.64 | 0.54 |
Data presented as median (IQR).
a
Change from baseline to week 48 represent the absolute change in values, except for lumbar spine and hip bone mineral density (BMD), where percentage change from baseline is shown. hsCRP, high-sensitivity C-reactive protein; IL-6, interleukin-6; LDL, low-density lipoprotein; mtDNA, mitochondrial DNA; PBMC, peripheral blood mononuclear cell; sTNFRI, soluble tumour necrosis factor receptor I; sTNFRII, soluble tumour necrosis factor receptor II; sVCAM1, soluble vascular cell adhesion molecule 1.