scholarly journals Effectiveness of strategies for nutritional therapy for patients with type 2 diabetes and/or hypertension in primary care: protocol of a systematic review of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030450 ◽  
Author(s):  
Julia Simões Corrêa Galendi ◽  
Renata Giacomini Occhiuto Ferreira Leite ◽  
Adriana Lúcia Mendes ◽  
Vania dos Santos Nunes-Nogueira

IntroductionDespite the increasing number of drugs available and various guidelines on the management of type 2 diabetes mellitus (T2DM) and hypertension, an expressive number of patients continue with these diseases uncontrolled. Nutrition therapy (NT) plays a fundamental role in the prevention and management of these comorbidities, as well as in the prevention of complications related to them. The objective of this review is to evaluate the effectiveness of NT strategies in the management of patients with T2DM and/or hypertension in primary care. The selected strategies did not substitute pharmaceutical treatment but instead focused on preventing a sedentary lifestyle and stimulating healthy nutrition.Methods and analysisWe will perform a systematic review according to Cochrane methodology of randomised controlled trials, wherein patients with T2DM and/or hypertension were allocated into one of the two groups: NT strategy, which may be of dietary quality or energy restriction, and conventional treatment. The primary outcomes will be glycaemic and blood pressure (BP) control, measured by final glycosylated hemoglobin (HbA1c) (%) and BP (mm Hg), respectively. Four general and adaptive search strategies have been created for the Embase, Medline, Latin American and Caribbean Health Sciences Literature (LILACS) and Cochrane Central Register of Controlled Trials (CENTRAL) electronic databases. Two reviewers will independently select eligible studies, assess the risk of bias and extract data from the included studies. Similar outcomes measured in at least two trials will be plotted in the meta-analysis using Review Manager V.5.3. The quality of evidence of the effect estimate of the intervention will be generated according to the Grading of Recommendations Assessment, Development, and Evaluation Working Group.Ethics and disseminationAs no primary data collection will be undertaken, formal ethical assessment is not required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press.PROSPERO registration numberOur systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 December 2018 (Registration number CRD42018118117).


BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034481 ◽  
Author(s):  
Renata Giacomini Oliveira Ferreira Leite ◽  
Luísa Rocco Banzato ◽  
Julia Simões Corrêa Galendi ◽  
Adriana Lucia Mendes ◽  
Fernanda Bolfi ◽  
...  

IntroductionDespite the increasing number of drugs and various guidelines on the management of type 2 diabetes mellitus (T2DM), several patients continue with the disease uncontrolled. There are several non-pharmacological treatments available for managing T2DM, but various of them have never been compared directly to determine the best strategies.ObjectiveThis study will evaluate the comparative effects of non-pharmacological strategies in the management of T2DM in primary care or community settings.Methods and analysisWe will perform a systematic review and network meta-analysis (NMA), and will include randomised controlled trials if one of the following interventions were applied in adult patients with T2DM: nutritional therapy, physical activity, psychological interventions, social interventions, multidisciplinary lifestyle interventions, diabetes self-management education and support (DSMES), technology-enabled DSMES, interventions delivered only either by pharmacists or by nurses, self-blood glucose monitoring in non-insulin-treated T2DM, health coaching, benchmarking and usual care. The primary outcome will be glycaemic control (glycated haemoglobin (HbA1c) (%)), and the secondary outcomes will be weight loss, quality of life, patient satisfaction, frequency of cardiovascular events and deaths, number of patients in each group with HbA1c <7, adverse events and medication adherence. We have developed search strategies for Embase, Medline, Latin American and Caribbean Health Sciences Literature, Cochrane Central Register of Controlled Trials, Trip database, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature Australasian Medical Index and Chinese Biomedical Literature Database. Four reviewers will assess the studies for their eligibility and their risk of bias in pairs and independently. An NMA will be performed using a Bayesian hierarchical model, and the treatment hierarchy will be obtained using the surface under the cumulative ranking curve. To determine our confidence in an overall treatment ranking from the NMA, we will follow the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationAs no primary data collection will be undertaken, no formal ethical assessment is required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press.PROSPERO registration numberCRD42019127856.





Author(s):  
Claudia Coelho ◽  
Rachel Agius ◽  
James Crane ◽  
Barbara McGowan

Background: Clinically significant weight loss improves glycaemic control and cardiovascular disease risk in patients with type 2 diabetes (T2DM).Aim: To identify and assess the efficacy of medical treatments for weight loss in adults with T2DM.Methods: A systematic review was conducted of peer- reviewed literature between July 2004 and July 2020 via PubMed, Embase, Web of Science, medRxiv and Cochrane Central Register of Controlled Trials. Randomised controlled trials (RCTs) in English investigating medical treatments for weight loss in patients with T2DM were included. RCTs of pharmacotherapy withdrawn from the market were excluded. No minimum length of follow-up time was established. Outcomes of interest were changes from baseline in body weight (%), changes from baseline in HbA1c (%, mmol/mol) and proportion of patients who achieved ≥5% weight loss. Quality assessment was evaluated using the Jadad score.Results: Fifteen RCTs were included with a total of 4,207 participants with T2DM. Interventions included medications approved for obesity management (orlistat, liraglutide, naltrexone-bupropion and phentermine-topiramate) and other agents investigated for the primary purpose of weight loss (topiramate, metreleptin, dapagliflozin and exenatide) compared with placebo. The duration of the intervention varied from 12 to 56 weeks. Placebo-adjusted body weight loss ranged from 2.2% to 7.3%. Furthermore, 30.5–77.0% of patients achieved ≥5% weight loss. Placebo-adjusted change in glycated haemoglobin was 0.3–1.5% (3.3–16.4 mmol/mol).Conclusion: Current evidence demonstrates that pharmacotherapy for weight loss, except for leptin, is associated with weight loss and glycaemic improvement in patients with T2DM.





Sign in / Sign up

Export Citation Format

Share Document