Oxygen (O2) kinetics during early recovery from peak exercise in patients with type 2 diabetes

Aims To examine the oxygen (O₂) kinetics during early recovery from peak exercise in patients with Type 2 diabetes and to examine whether oxygen O₂ recovery is associated with fasting glucose and HbA_1c in this population.

Methods Eighty-nine participants (52 men) aged 51.8 ± 7.1 years (mean ± sd) were divided into three groups: normal weight (BMI ≤ 25.0 kg/m²), overweight/obese without diabetes (BMI ≥ 26 kg/m²) and overweight/obese with Type 2 diabetes. Participants were assessed for their aerobic power (VO_2peak) on a cycle ergometer, provided a fasting blood sample and underwent a series of anthropometric measurements. Early recovery period was measured for 60 s from cessation of exercise and expressed as percentage of VO_2peak (higher percentage represents slower recovery).

Results No significant differences were observed for age between the three study groups. Both the overweight/obese groups without diabetes and with Type 2 diabetes had higher BMI than the normal weight group, with no significant differences between overweight/obese participants without diabetes and those with diabetes. Participants with Type 2 diabetes had lower VO_2peak than overweight/obese participants without diabetes and normal weight individuals (19.6 ± 4.8, 22.6 ± 5.4 and 25.7 ± 5.3 ml kg⁻¹ min⁻¹, respectively, P < 0.004 for overall trends). Participants with Type 2 diabetes also had slower recovery in oxygen O₂ kinetics after exercise, compared with both normal weight and overweight/obese individuals without diabetes (56.5 ± 7.7, 49.2 ± 7.2, 47.7 ± 7.4%, P < 0.004 for overall trends). Multiple regression analysis revealed that percentage of oxygen O₂ recovery was a stronger predictor than VO_2peak, BMI or age for fasting glucose and HbA_1c.

Conclusions Patients with Type 2 diabetes have lower VO_2peak and prolonged oxygen O₂ recovery from peak exercise. However, only prolonged oxygen O₂ recovery was associated with fasting glucose and HbA_1c.

Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures : vital D study

Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study.

Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.

Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.

Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.