Table 2.
Changes in Metabolic and Mitochondrial Parameters from Baseline to Week 48 for the 21 subjects who completed the study
| Variable | Switch Arm median (range) n=13 | Continuation Arm median (range)n=8 | P value (between arms) |
|---|---|---|---|
| BMI (kg/m2) | 0.4 (−2.3, 3.4) | −0.14 (−2.0, 5.6) | 0.56 |
| Glucose (mg/dL) | −4 (−23, 51) | 3 (−51, 18) | 0.91 |
| Triglycerides (mg/dL) | −38 (−606, 82) | 5 (−74, 64) | 0.16 |
| Total cholesterol (mg/dL) | −1 (−59, 24) | −11.5 (−44,11) | 0.56 |
| HDL cholesterol (mg/dL) | 6 (−11, 15) | 0 (−35, 16) | 0.15 |
| Resting lactate (mmol/L) | −0.27 (−1.2, 0.25)* | 0.14 (−2.6, 3.6) | 0.08 |
| Resting pyruvate | −0.01 (−0.06, 0.03) | 0.02 (−0.04, 0.19) | 0.54 |
| Fat mtDNA (copies/cell) | 40 (−49, 261)* | 36 (−97, 115) | 0.36 |
| % Fat mtDNA | 67 (−34 to 356)* | 28 (−54 to 151) | 0.20 |
| PBMC mtDNA (copies/cell) | 1.5 (−9, 121) | −2.5 (−46, 8) | 0.22 |
| Lipoatrophy score (physician) | −1 (−4, 2) | −1 (−6, 5) | 0.80 |
| Lipoatrophy score (patient) | 1 (−4, 2) | 0 (−2,1) | 0.26 |
| Lipohypertrophy score (physician) | −1 (−3,3) | 0 (0−3) | 0.04 |
| Lipohypertrophy score (patient) | 0 (−2, 5) | 0 (−3,2) | 0.15 |
| Total lean body mass (grams) | −155 (−4917, 6261) | −187 (−3176, 3911) | 0.45 |
| Trunk fat (grams) | 804 (−4356, 2898) | −50 (−1560, 7233) | 0.80 |
| Limb fat (grams) | 189 (−2256, 3173) | −194 (−1160, 5098) | 0.45 |
| % Limb fat | 6.9 (−23.8 to 34.4) | −5.0 (−39.8 to 92.4) | 0.23 |
| % Bone mineral density | 0.0 (−1.2, 4) | −1.7% (−6.3, 0.8)* | 0.003 |
*
within-arm changes; p<0.05