Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial.
ABSTRACT Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations.
We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869.
Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups.
An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit.
Diabetes UK and the UK Department of Health.
SourceAvailable from: Manuel Hernández-Triana[Show abstract] [Hide abstract]
ABSTRACT: http://www.hoajonline.com/journals/pdf/2052-6954-2-3.pdf ISSN 2052-6954 Background: Acceptable results have been observed in Cuban, and Chinese diabetic type 2 patients treated during 21 days with Ma-Pi 2 vegetarian macrobiotic diet. The study aim was to evaluate the reproducibility of these results in Tamale, Ghana, as a part of the multicenter study promoted by UPM, A Macrobiotic Point, Italy. Methods: A 21 day dietary intervention was carried out in 23 adult patients with type 2 diabetes mellitus.The diet consisted of whole cereals, vegetables, legumes, sesame seeds, seaweeds, soy fermented products and green tea. Patients were hospitalized during the study in the Tamale Teaching Hospital. In order to evaluate the effect of the diet, records of anthropometric measurements, body composition, biochemical indicators, blood pressure, clinical evaluation and medication adjustments, were carried out. Data at onset and at termination were compared. Results: Despite the limitations of the intervention (small and non random selected sample, physical inactivity, and vegetable scarcities), significant reductions were recorded on: glycosemia, 47%; fructosemia, 27%; leukocytes, 20%; blood urea, 23%; and insulin consumption, 44%. The urine pH increased by 10%, which was evidence of a lower metabolic acidosis level after the diet. Conclusions: The fast improvement of the glucose metabolic control, parallel to the significant reduction in insulin consumption evidenced the therapeutic benefit of the Ma-Pi 2 diet. These encouraging results, though preliminary, should be additionally extended in further research addressed to describe the underlying metabolic mechanisms. An additional study with a control group receiving the prescribed standard diet for type 2 diabetic patients is recommended. doi: 10.7243/2052-6954-2-3
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ABSTRACT: For the detection of unwanted outcomes of new interventions, physicians rely on adverse event reporting. We attempt to quantify the reported incidence of venous thromboembolism (VTE) and arterial thrombosis (AT) in randomized clinical trials (RCTs), and evaluate the extent of under-reporting. We selected all therapeutic RCTs published in the four highest-impact general medicine journals between January 2011 and July 2011. Patients were categorized according to VTE risk. The occurrences of VTE and AT, either as predefined outcome or adverse event, were assessed. We identified 131 RCTs. VTE and AT were not reported in 89 and 70 % of these studies, respectively. The raw-unweighted reported incidence in the 3 studies with predefined outcomes for VTE was 8.4 (7.8-9.1) per 1,000 person-years. In the 128 studies without predefined outcomes for VTE, (consisting of 322,029 individuals, including patients with cancer, inflammatory disease, cardiovascular disease, surgery, adding up to a follow-up >500,000 person-years), an incidence of 0.4 (0.4-0.5) per 1,000 person-years was found. The reported incidence of AT in 18 studies in which AT was part of predefined outcomes was 25.6 (24.9-26.3) per 1,000 person-years. In 92 studies without predefined outcomes for AT (231,638 individuals, follow-up >200,000 person-years,), the incidence was 2.5 (2.3-2.7) per 1,000 person-years. The incidence of VTE and AT in RCTs is highly under-reported. Uniform registration of adverse events, even when unlikely to be related to the intervention, is necessary to be able to inform physicians about the potential toxicities of new therapeutic strategies.Internal and Emergency Medicine 12/2014; 10(2). DOI:10.1007/s11739-014-1168-2 · 2.41 Impact Factor
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ABSTRACT: We conducted a systematic review to investigate the cross-sectional and prospective associations of accelerometer-measured total sedentary time and breaks in sedentary time with individual cardiometabolic biomarkers in adults ≥18 years of age. Ovid Medline, Embase, Web of Science and the Cochrane Library were searched for studies meeting the inclusion criteria. Due to inconsistencies in the measurement and analysis of sedentary time, data was synthesised and presented narratively rather than as a meta-analysis. Twenty-nine studies were included in the review; twenty-eight reported on total sedentary time and six on breaks in sedentary time. There was consistent evidence from cross-sectional data of an unfavourable association between total sedentary time and insulin sensitivity. There was also some evidence of unfavourable associations with fasting insulin, insulin resistance and triglycerides. Furthermore, there was some evidence from cross-sectional data of a favourable association between breaks in sedentary time and triglycerides. Total sedentary time was consistently shown to be associated with poorer insulin sensitivity, even after adjusting for time spent in physical activity. This finding supports the proposed association between sedentary time and the development of Type 2 diabetes and reinforces the need to identify interventions to reduce time spent sedentary. Copyright © 2015. Published by Elsevier Inc.Preventive Medicine 04/2015; 8. DOI:10.1016/j.ypmed.2015.04.013 · 2.93 Impact Factor