The power of the placebo effect in diabetes: A systematic review and meta-analysis.

This review aims to identify the magnitude of the placebo effect in people with type 2 diabetes mellitus. Literature research was conducted Medline, Embase and Virtual Health Library for studies published between the date of inception and June 2021. The eligibility criteria included randomized controlled trials, showing comparison to placebo, having participants with type 2 diabetes mellitus, and having glycated hemoglobin (HbA1c) as the primary outcome. Meta-analysis was conducted with the effect of changing HbA1c in relation to the baseline. Exploration of heterogeneity was performed.The meta-analysis showed an increase in the average of HbA1c compared to the baseline of 0.14% (95% CI: 0.07-0.21). There was a significant difference between follow-up times (p = 0.03) and between administration routes (p = 0.01), with an increase in HbA1c in the oral route [0.15% (95% CI: 0.07-0.23)]. The meta-regression of the year of publication showed a significant downward trend (p = 0.01) of the increase in HbA1c compared to the baseline.In this study, the expected placebo effect of Hba1c reduction was not found; instead, higher Hba1c levels were observed in the control groups, although this effect was reduced over the years. Registration: PROSPERO ID CRD42020172797.

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial.

BACKGROUND: Community health workers are community members who provide education and care for patients for a broad range of health issues, including diabetes mellitus. However, few community health workers are trained for diabetes education and little is known about the effectiveness of their interventions. The aim of this study is to evaluate the effect of a diabetes education program delivered to community health workers in improving the metabolic control of patients with type 2 diabetes mellitus. METHODS: Eight community health workers, providing care for 118 patients, were randomized in two groups to receive a 1-month diabetes education program (intervention, patients n = 62) or an education course in other health issues (control, patients n = 56). Each community health worker was responsible for transmitting the acquired knowledge to patients. Primary outcome was changed in HbA1C 3 months after the intervention. RESULTS: PARTICIPANTS: Mean age was 61 ± 11 years, 35% were men and 62% were whites. HbA1c levels reduced in both groups (intervention: 9.1 ± 2.2 vs. 7.9 ± 1.9%; control: 9.1 ± 2.1 vs. 8.4 ± 2.5%, p < 0.001), but no statistically significant differences were observed between groups (p between groups = 0.13). Total cholesterol (intervention: 192 ± 43 vs. 182 ± 39 mg/dl; control: 197 ± 44 vs. 191 ± 45 mg/dl, p between groups = 0.035) and triglycerides (intervention: 158 [106-218] vs. 135 [106-215]; control: 128 [100-215] mg/dl vs. 146 [102-203] mg/dl, p between groups = 0.03) reduced overtime only in intervention group. CONCLUSIONS: In this study, a significant decrease in HbA1c was observed during patients' follow-up, but it was similar in intervention and control groups. The diabetes mellitus education course delivered to community health workers was able to improve patients' lipid profile.

Association between physical activity advice only or structured exercise training with blood pressure levels in patients with type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: Diabetes is associated with marked cardiovascular morbidity and mortality. However, the association between different types of exercise training and blood pressure (BP) changes is not fully clear in type 2 diabetes. OBJECTIVE: The aim of this systematic review and meta-analysis of randomized controlled clinical trials (RCTs) was to determine the effects of structured exercise training (aerobic [AER], resistance [RES], or combined [COMB]) and physical activity (PA) advice only on BP changes in patients with type 2 diabetes. METHODS: Searches in five electronic databases were conducted to retrieve studies published from 1980 to 2013. Eligible studies were RCTs consisting of structured exercise training or PA advice versus no intervention in patients with type 2 diabetes. We used random effect models to derive weighted mean differences (WMDs) of exercises on absolute changes in systolic BP (SBP) and diastolic BP (DBP). RESULTS: A total of 30 RCTs of structured training (2,217 patients) and 21 of PA advice (7,323 patients) were included. Data were extracted independently in duplicate. Structured exercise was associated with reductions in SBP (WMD -4.22 mmHg; 95% confidence interval [CI] -5.89 to -2.56) and DBP (WMD -2.07 mmHg; 95% CI -3.03 to -1.11) versus controls. In structured exercise interventions, AER and RES were associated with declines in BP, and COMB was not associated with BP changes. However, in sensitivity analysis, a high-intensity protocol within COMB was associated with declines in SBP (WMD -3.30 mmHg; 95% CI -4.71 to -1.89). Structured exercise longer than 150 min/week was associated with greater BP reductions. PA advice only was associated with reduction in SBP (WMD -2.97 mmHg; 95% CI -4.52 to -1.43) and DBP (WMD -1.41 mmHg; 95% CI -1.94 to -0.88) versus controls. CONCLUSIONS: AER, RES, and high-intensity combined training are associated with BP reduction in patients with type 2 diabetes, especially in exercise programs lasting more than 150 min/week. PA advice only is also associated with lower BP levels.

Glucose tolerance status is a better predictor of diabetes and cardiovascular outcomes than metabolic syndrome: a prospective cohort study.

BACKGROUND: To evaluate the importance of oral glucose tolerance test (OGTT) in predicting diabetes and cardiovascular disease in patients with and without Metabolic Syndrome from a population treated in a primary care unit. RESEARCH DESIGN AND METHODS: A prospective cohort study was conducted with subjects regularly attending the primary care unit of Hospital de Clínicas de Porto Alegre. Participants underwent a 75 g OGTT. Metabolic syndrome definition was based on the criteria of IDF/AHA/NHLBI-2010. RESULTS: Participants mean age was 61 ± 12 years (males: 38%; whites: 67%). Of the 148 subjects included, 127 (86%) were followed for 36 ± 14 months, 21 (14%) were lost. Subjects were classified into four groups based on baseline OGTT: 29% normal (n = 43), 28% impaired fasting glucose (IFG; n = 42), 26% impaired glucose tolerance (IGT; n = 38), and 17% diabetes (n = 25). Metabolic syndrome prevalence was lower in normal group (28%), intermediate in IFG (62%) and IGT (65%) groups, and higher among subjects with diabetes (92%; P <0.001). Incidence of diabetes increased along with the stages of glucose metabolism disturbance (normal: 0%, IFG: 16%, IGT: 28%; P = 0.004). No patient with normal OGTT developed diabetes, regardless metabolic syndrome presence. Diabetes at baseline was the major determinant of cardiovascular disease occurrence (normal: 0%, IFG: 4%, IGT: 0%, diabetes: 24%; P = 0.001). In Cox-regression analysis, only the 2 h OGTT results were associated with diabetes (OR = 1.03; 95%CI 1.01-1.06; P <0.001) and cardiovascular disease development (OR = 1.013; 95%CI 1.002-1.025; P = 0.024). CONCLUSIONS: In this sample of subjects undergoing diabetes screening, the OGTT predicted diabetes and cardiovascular disease more effectively than the metabolic syndrome status.