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临床试验/NCT04045938
NCT04045938Unknown不适用

A Systematic Review and Meta-analysis of Randomized Controlled Trials of the Effect of Low Glycemic Index or Low Glycemic Load Diets on Cardiometabolic Risk Factors in Diabetes

University of Toronto1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1
试验地点
1
主要终点
HbA1c

研究概览

简要总结

Low glycemic index and low glycemic load diets have been shown to improve glycemic control and cardiometabolic risk factors in randomized controlled trials in people with diabetes and are associated with reduced incidence of diabetes and cardiovascular disease in prospective cohort studies inclusive of people with diabetes. These benefits have been recognized in the most recent updates of the clinical practice guidelines for the management of diabetes from the U.S., Canada, UK, and Australia. The European Association for the Study of Diabetes (EASD) also recommends low-GI/GL diets but has not updated their guidance in 15 years. To support the update of the EASD clinical practice guidelines for nutrition therapy, the investigators conducted a systematic review and meta-analysis of the totality of the available evidence from randomized controlled trials of the effect of low GI/GL dietary patterns on glycemic control and other established cardiometabolic risk factors in individuals with diabetes. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.

详细描述

Background: The prevalence of diabetes continues to rise globally and remains a major cause of cardiovascular disease and a leading cause of death. Diet and lifestyle remain the cornerstone of therapy for diabetes prevention and management. Approaches that target postprandial glycemic excursions may have particular advantages. Low glycemic index (GI) and low glycemic load (GL) diets have been shown to improve glycemic control and cardiometabolic risk factors in randomized controlled trials in people with diabetes and are associated with reduced incidence of diabetes and cardiovascular disease in prospective cohort studies inclusive of people with diabetes. These benefits have been recognized in the most recent updates of the clinical practice guidelines for diabetes from the U.S., Canada, UK, and Australia. The European Association for the Study of Diabetes (EASD) also recommends low-GI/GL diets but has not updated their guidance in 15 years.

Need for proposed research: High quality systematic reviews and meta-analyses of randomized controlled trials represent the highest level of evidence to support dietary guidelines and public health policy development. As dietary guidelines and public health policy have shifted toward food and dietary-pattern based recommendations, there is a need for systematic reviews and meta-analyses comparing the role of low GI/GL diets in the management of diabetes.

Objective: To support the update the European Association for the Study of Diabetes (EASD) clinical practice guidelines for nutrition therapy, the investigators conducted a systematic review and meta-analysis of randomized controlled trials using the GRADE approach of the effect of low GI/GL dietary patterns on glycemic control and other established cardiometabolic risk factors in individuals with diabetes.

Design: The systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).

Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by manual searches of references of included studies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Dietary trials in humans
  • Randomized treatment allocation
  • Suitable control (i.e. isocaloric diet that is not low GI or low GL)
  • Viable endpoint data

排除标准

  • Non-human studies
  • Non-randomized treatment allocation
  • <3 weeks
  • Lack of a suitable control (i.e. non-isocaloric)
  • No viable endpoint data

结局指标

主要结局

HbA1c

时间窗: Up to 20-years

Mean Difference

次要结局

  • Glycemic control - Fasting blood glucose(Up to 20-years)
  • Blood lipids - non-HDL-cholesterol(Up to 20-years)
  • Blood lipids - apo B(Up to 20-years)
  • Blood lipids - LDL-cholesterol(Up to 20-years)
  • Blood lipids - Triglycerides(Up to 20-years)
  • Glycemic control - Fasting blood insulin(Up to 20-years)
  • Blood lipids - HDL-cholesterol(Up to 20-years)
  • Adiposity - Body Weight(Up to 20-years)
  • Adiposity - Body Mass Index (BMI)(Up to 20-years)
  • Blood pressure - systolic blood pressure(Up to 20-years)
  • Blood pressure - diastolic blood pressure(Up to 20-years)
  • Adiposity - Waist Circumference(Up to 20-years)
  • Inflammation - C-reactive protein (CRP)(Up to 20-years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Sievenpiper

Associate Professor

University of Toronto

研究点 (1)

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