Data on weight gain and the progression to overweight/obesity in HIV-infected persons during initial combination antiretroviral therapy (cART) are limited, and comparisons to the general population are inconclusive. Weight and body mass index (BMI) changes were studied in HIV-infected adults who remained on initial cART for 12 consecutive months and in an HIV-uninfected cohort receiving care at Duke University Medical Center between 1998 and 2008. Overweight/obesity was defined as BMI ‡ 25 kg/m 2 . Variables were analyzed by Chisquare and Student's t-tests. Ninety-two HIV-infected persons (median age 38.2 years) met inclusion criteria. Weight and BMI increased during 12 months of cART (80.0 to 84.4 kg, p < 0.0001; 26.4 to 27.9 kg/m 2 , p < 0.0001; respectively). Weight gain was greater in HIV-infected females compared to males (8.6 vs. 3.6 kg, p = 0.04), in persons treated with protease inhibitor (PI)-based cART compared to non-PI-based cART (9.0 vs. 2.7 kg, p = 0.001), and in persons with a pretreatment CD4 count < 200 cells/mm 3 compared to ‡ 200 cells/mm 3 (8.9 vs. 0.3 kg, p < 0.0001). Overweight/obesity prevalence increased from 52% to 66% during 12 months of initial cART, a 27% relative increase ( p = 0.002). HIV-infected persons had a lower prevalence of pretreatment overweight/ obesity compared to 94 age-matched control subjects (52% vs. 91%, p < 0.001); however, there was no change in weight (92.7 vs. 93.0 kg, p = 0.5) or overweight/obesity prevalence (91% to 92%, p > 0.9) during 12 months in the control cohort. Management should anticipate excess weight gain during the first year of cART in persons who are female, have a pretreatment CD4 < 200 cells/mm 3 , or will initiate PI-based cART.

Aims/hypothesis Clinical trials assessing interventions for treating and preventing diabetes mellitus and its complications are needed to inform evidence-based practice. To examine whether current studies adequately address these needs, we conducted a descriptive analysis of diabetesrelated trials registered with ClinicalTrials.gov from 2007 to 2010. Methods From a dataset including 96,346 studies registered in ClinicalTrials.gov downloaded on 27 September, 2010, a subset of 2,484 interventional trials was created by selecting trials with disease condition terms relevant to diabetes. Results Of the diabetes-related trials, 74.8% had a primarily therapeutic purpose while 10% were preventive. Listed interventions included drugs (63.1%) and behavioural (11.7%). Most trials were designed to enrol ≤500 (91.1%) or ≤100 (58.6%) participants, with mean/median times to completion of 1.8/1.4 years. Small percentages of trials targeted persons aged ≤18 years (3.7%) or ≥65 years (0.6%), while 30.8% excluded patients >65 years and the majority excluded those >75 years. Funding sources included industry (50.9%), NIH (7.5%) or other, with most being single-centre trials of other sponsorship (37.7%) or industryfunded multicentre studies (27.4%). A small number of trials (1.4%) listed primary outcomes including mortality or clinically significant cardiovascular complications. The distribution of trials by global region and US state does not correlate with prevalence of diabetes. Conclusions/interpretation The majority of diabetes-related trials include small numbers of participants, exclude those at the extremes of age, are of short duration, involve drug therapy rather than preventive or non-drug interventions and do not focus upon significant cardiovascular outcomes. Recently registered diabetes trials may not sufficiently address important diabetes care issues or involve affected populations.

The global burden of osteoporotic fractures is associated with significant morbidity, mortality, and healthcare costs. We examined the ClinicalTrials.gov database to determine whether recently registered clinical trials addressed prevention and treatment in those at high risk for fracture. A dataset of 96,346 trials registered in ClinicalTrials.gov was downloaded on September 27, 2010. At the time of the dataset download, 40,970 interventional trials had been registered since October 1, 2007. The osteoporosis subset comprised 239 interventional trials (0.6%). Those trials evaluating orthopedic procedures were excluded. The primary purpose was treatment in 67.0%, prevention in 20.1%, supportive care in 5.8%, diagnostic in 2.2%, basic science in 3.1%, health services research in 0.9%, and screening in 0.9%. The majority of studies (61.1%) included drug-related interventions. Most trials (56.9%) enrolled only women, 38.9% of trials were open to both men and women, and 4.2% enrolled only men. Roughly one fifth (19.7%) of trials excluded research participants older than 65 years, and 33.5% of trials excluded those older than 75 years. The funding sources were industry in 51.0%, the National Institutes of Health in 6.3%, and other in 42.7%. We found that most osteoporosis-related trials registered from October 2007 through September 2010 examined the efficacy and safety of drug treatment, and fewer trials examined prevention and non-drug interventions. Trials of interventions that are not required to be registered in ClinicalTrials.gov may be underrepresented. Few trials are specifically studying osteoporosis in men and older adults. Recently registered osteoporosis trials may not sufficiently address fracture prevention.

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Abnormal BMD was prevalent in most pre-lung transplant subjects, with striking differences noted in comparison with a healthy, matched cohort. Lateral chest radiographs in combination with BMD data give a more complete picture of bone abnormalities. Osteoporosis screening prior to lung transplantation should be performed to identify high-risk subjects for fracture and allow for intervention.

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