The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up.

CONTEXT: Gestational diabetes (GDM) confers a high risk of type 2 diabetes. In the Diabetes Prevention Program (DPP), intensive lifestyle (ILS) and metformin prevented or delayed diabetes in women with a history of GDM. OBJECTIVE: The objective of the study was to evaluate the impact of ILS and metformin intervention over 10 years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study. DESIGN: This was a randomized controlled clinical trial with an observational follow-up. SETTING: The study was conducted at 27 clinical centers. PARTICIPANTS: Three hundred fifty women with a history of GDM and 1416 women with previous live births but no history of GDM participated in the study. The participants had an elevated body mass index and fasting glucose and impaired glucose tolerance at study entry. INTERVENTIONS: Interventions included placebo, ILS, or metformin. OUTCOMES MEASURE: Outcomes measure was diabetes mellitus. RESULTS: Over 10 years, women with a history of GDM assigned to placebo had a 48% higher risk of developing diabetes compared with women without a history of GDM. In women with a history of GDM, ILS and metformin reduced progression to diabetes compared with placebo by 35% and 40%, respectively. Among women without a history of GDM, ILS reduced the progression to diabetes by 30%, and metformin did not reduce the progression to diabetes. CONCLUSIONS: Women with a history of GDM are at an increased risk of developing diabetes. In women with a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study, both lifestyle and metformin were highly effective in reducing progression to diabetes during a 10-year follow-up period. Among women without a history of GDM, lifestyle but not metformin reduced progression to diabetes.

Prevalence of pain and association with quality of life, depression and glycaemic control in patients with diabetes.

AIMS: To determine the prevalence of pain and its association with glycaemic control, mental health and physical functioning in patients with diabetes. METHODS: Cross-sectional data from a multi-site, prospective cohort study of 11 689 participants with diabetes. We analysed the associations of pain severity and interference with glycated haemoglobin (HbA(1c)) measurements and Medical Outcomes Study SF-Mental and Physical Component Summary-12 (MCS-12 and PCS-12) scores. RESULTS: Of participants, 57.8% reported moderate to extreme pain and, compared with those without pain, were somewhat older (60.8 vs. 59.9 years, P < 0.001), more obese (body mass index of 32.1 vs. 29.8 kg/m(2), P < 0.001), more likely to report being depressed or anxious (41.3 vs. 16.2%, P < 0.001) and more likely to report fair or poor health (48.5 vs. 23.1%, P < 0.001). Bivariate comparisons demonstrated that patients with extreme pain had higher HbA(1c) than those without pain (8.3 vs. 8.0%, P = 0.001). In multivariable analyses, pain was not associated with HbA(1c) (P = 0.304) but was strongly associated with worse MCS-12 (P < 0.001), PCS-12 (P < 0.001) and depression (P < 0.001). Depression was 1.3 (95% CI: 1.12, 1.96) times more likely in patients with moderate pain and 2.0 (95% CI: 1.56, 2.46) times more likely in patients with extreme pain. CONCLUSIONS: Moderate to extreme pain was present in 57.8% of diabetic patients. Pain was strongly associated with poorer mental health and physical functioning, but not worse glycaemic control. Recognizing the high prevalence of pain and its strong association with poorer health-related quality of life may be important to improve the comprehensive management of diabetes.

Physicians' participatory decision-making and quality of diabetes care processes and outcomes: results from the triad study.

OBJECTIVES: In participatory decision-making (PDM), physicians actively engage patients in treatment and other care decisions. Patients who report that their physicians engage in PDM have better disease self-management and health outcomes. We examined whether physicians' diabetes-specific treatment PDM preferences as well as their self-reported practices are associated with the quality of diabetes care their patients receive. METHODS: 2003 cross-sectional survey and medical record review of a random sample of diabetes patients (n=4198) in 10 US health plans across the country and their physicians (n=1217). We characterized physicians' diabetes care PDM preferences and practices as 'no patient involvement,' 'physician-dominant,' 'shared,' or 'patient-dominant' and conducted multivariate analyses examining their effects on the following: (1) three diabetes care processes (annual hemoglobin A1c test; lipid test; and dilated retinal exam); (2) patients'satisfaction with physician communication; and (3) whether patients' A1c, systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL) were in control. RESULTS: Most physicians preferred 'shared' PDM (58%) rather than 'no patient involvement' (9%), 'physician-dominant' (28%) or 'patient dominant' PDM (5%). However, most reported practicing 'physician-dominant' PDM (43%) with most of their patients, rather than 'no patient involvement' (13%), 'shared' (37%) or 'patient-dominant' PDM (7%). After adjusting for patient and physician-level characteristics and clustering by health plan, patients of physicians who preferred 'shared' PDM were more likely to receive A1c tests [90% vs. 82%, AOR: 2.05, 95% CI: 1.03-3.07] and patients of physicians who preferred 'patient-dominant' treatment decision-making were more likely to receive lipid tests [60% vs. 50%, AOR: 1.58, 95% CI: 1.04-2.39] than those of providers who preferred 'no patient involvement' in treatment decision-making. There were no differences in patients' satisfaction with their doctor's communication or control of A1c, SBP or LDL depending on their physicians' PDM preferences. Physicians' self-reported PDM practices were not associated with any of the examined aspects of diabetes care in multivariate analyses. CONCLUSIONS: Patients whose physicians prefer more patient involvement in decision-making are more likely than patients whose physicians prefer more physician-directed styles to receive some recommended risk factor screening tests, an important first step toward improved diabetes outcomes. Involving patients in treatment decision-making alone, however, appears not to be sufficient to improve biomedical outcomes.

Garlic shows promise for improving some cardiovascular risk factors.

OBJECTIVES: To summarize the effects of garlic on several cardiovascular-related factors and to note its adverse effects. METHODS: English and non-English citations were identified from 11 electronic databases, references, manufacturers, and experts from January 1966 through February 2000 (depending on the database searched). Reports of cardiovascular-related effects were limited to randomized controlled trials lasting at least 4 weeks. Reports of adverse effects were not limited by study design. From 1798 pertinent records, 45 randomized trials and 73 additional studies reporting adverse events were identified. Two physicians abstracted outcomes and assessed adequacy of randomization, blinding, and handling of dropouts. Standardized mean differences of lipid outcomes from placebo-controlled trials were adjusted for baseline differences and pooled using random effects methods. RESULTS: Compared with placebo, garlic preparations may lead to small reductions in the total cholesterol level at 1 month (range of average pooled reductions, 0.03-0.45 mmol/L [1.2-17.3 mg/dL]) and at 3 months (range of average pooled reductions 0.32-0.66 mmol/L [12.4-25.4 mg/dL]), but not at 6 months. Changes in low-density lipoprotein levels and triglyceride levels paralleled total cholesterol level results; no statistically significant changes in high-density lipoprotein levels were observed. Trials also reported significant reductions in platelet aggregation and mixed effects on blood pressure outcomes. No effects on glycemic-related outcomes were found. Proven adverse effects included malodorous breath and body odor. Other unproven effects included flatulence, esophageal and abdominal pain, allergic reactions, and bleeding. CONCLUSIONS: Trials suggest possible small short-term benefits of garlic on some lipid and antiplatelet factors, insignificant effects on blood pressure, and no effect on glucose levels. Conclusions regarding clinical significance are limited by the marginal quality and short duration of many trials and by the unpredictable release and inadequate definition of active constituents in study preparations.