All study personnel and participants were blinded to treatment assignment for the duration of the study period. The study medication (Genotropin or placebo) was injected subcutaneously in the afternoon at between 1 and 3 pm GSK1120212 clinical trial for 40 weeks . If moderate or severe adverse effects occurred during the placebo-controlled period, the dose could be reduced to 0.4 mg. Single-slice CT scanning (Somatom Sensation 10; Siemens, Surrey, UK) was performed at baseline and at week 40, at the upper limit of L4, to estimate visceral and subcutaneous fat areas, and at 20 cm proximal to the
upper edge of the patella at the right femur, to estimate femur subcutaneous fat areas. One radiologist, who was blinded to the patients’ clinical data and treatment groups, analysed all scans. Whole-body DEXA scanning [Hologic QDR-2000 W (Bedford, MA, USA) in single beam mode; in vivo coefficient of variation (CV) 1.6 for total and 3.2 for regional fat mass (10 duplicate measurements)] was performed at baseline and at week 40 to estimate the amount of fat in the trunk and the extremities.
The trunk was defined as the region including the DAPT chest, abdomen and pelvis. The upper limit of the leg region was placed through the hip joints at an angle of approximately 45°, and the upper limit of the arm region was placed vertically through the shoulder joints. Peripheral or limb fat mass was defined as the sum of arm and leg fat masses. The percentage of limb fat was calculated as (limb fat mass/total fat mass) × 100%. Waist circumference was measured at the level between the rib curvature and the crista iliaca after a normal expiration while the subject was standing, hip circumference at the level of the maximal circumference, and thigh circumference at a level 20 cm proximal to the upper limit of the patella
on both legs. All measures were performed at baseline, and at weeks 26 and 40, in duplicate by the Montelukast Sodium same investigator, and mean values were recorded. The Department of Clinical Biochemistry, Hvidovre, performed CD4 cell counts and measured total cholesterol, triglycerides (TG), high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, and low-density lipoprotein (LDL) cholesterol at baseline, and at weeks 26 and 40. Plasma glucose was measured at screening, baseline, and weeks 1, 4, 12, 26 and 40 by the glucose-oxidase method (ABL 800 Flex; Radiometer, Copenhagen, Denmark). The blood sample for glucose measurement was stored on ice immediately, and analysed within 10 min after sampling. A standard 75 g oral glucose tolerance test (OGTT), as previously described , was performed at baseline and at week 40. HIV RNA was measured by a Roche Amplicor ultrasensitive assay (Roche, Basel, Switzerland) at baseline, and at weeks 26 and 40. The detection threshold for HIV RNA was 40 copies/mL.