Long-term Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Type 2 diabetes (T2D), a prevalent metabolic disorder impacting >3 million Canadians, is characterized by insulin resistance and high blood glucose. Chronically elevated blood glucose (i.e., hyperglycemia) and swings in glucose (i.e., glucose variability) contribute to complications of T2D. Specifically, post-meal hyperglycemic spikes are independent risk factors for cardiovascular disease and mortality. People with T2D often exhibit a different circadian pattern from healthy individuals, with higher glucose excursions in the morning, after breakfast. This makes breakfast a crucial meal in achieving glycemic control. One strategy to reduce or eliminate this high glucose excursion is to consume a low-carbohydrate breakfast. Our recently published 3-month clinical trial (Oliveira et al., AJCN 2023) - funded by the Egg Farmers of Canada (EFC) & Egg Nutrition Center (ENC) - highlighted the positive impact of a simple dietary intervention, where individuals were advised to consume an egg-based, low-carbohydrate breakfast. This intervention led to improved glycemic control assessed by continuous glucose monitoring and reduced overall energy and carbohydrate intake when compared to a low-fat guideline breakfast. While we saw a within-group reduction HbA1c in the egg-based low-carbohydrate breakfast group, the between group difference did not reach statistical significance. Since HbA1c reflects the average glucose over the preceding 3 months, likely, our previous study's duration was not long enough to demonstrate significant reductions in HbA1c. For a low-carbohydrate breakfast to be recognized as an evidence-based strategy in nutrition and clinical practice guidelines, a longer-term study that demonstrates reductions in HbA1c is needed.
Collectively, our promising early results demonstrate that the time is right and that our team is poised to deliver a longer, well-powered randomized controlled trial (RCT) to solidify low-carbohydrate breakfasts as an evidence-based strategy to improve glucose control and improve health outcomes for people living with T2D.
详细描述
Research Question: Does the advice and guidance to consume a long-term low-carbohydrate breakfast impact blood glucose levels in people with type 2 diabetes?
Objectives
The specific aims are to conduct a RCT to determine if advice and guidance to consume a low-carbohydrate breakfast, compared to standard guidelines control breakfast, for one year:
Improves glycemic control assessed by HbA1c (primary outcome) in individuals with type 2 diabetes (T2D); Improves glycemic variability and lowers postprandial hyperglycemia in individuals with T2D; Reduces body weight and fat mass in individuals with T2D; Reduces feelings of hunger and consequently lowers daily energy and carbohydrate intake in individuals with T2D.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) physician-diagnosed T2D, ii) 30-79 years old and iii) on stable medication for at least 3 months
排除标准
- •i) Use of exogenous insulin; ii) taking more than 3 glucose lowering medications; iii) ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, or kidney disorders; iv) allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets; v) being unable to follow the controlled diet instructions; vi) currently following a low-carbohydrate or very low-carbohydrate diet (ketogenic diet); vii) currently pregnant or lactating, or planning on becoming pregnant within the next 12 months; viii) with scheduled surgery or medical intervention that prevents following study diet; and ix) being unable to follow remote guidance by internet or smartphone.
结局指标
主要结局
HbA1c
时间窗: At baseline and after 12 months
Blood HbA1c
次要结局
- 24 h average glucose by continuous glucose monitoring(Baseline, 6 and 12 months)
- Post-meal areas under the curve [AUC] glucose by continuous glucose monitoring(Baseline, 6 and 12 months)
- Glycemic variability by continuous glucose monitoring(Baseline, 6 and 12 months)
- Body weight(Baseline, 3, 6, 9 and, 12 months)
- Body mass index(Baseline, 3, 6, 9 and, 12 months)
- Waist circumference(Baseline, 3, 6, 9 and, 12 months)
- Triglycerides(Baseline and 12 months)
- Total cholesterol(Baseline and 12 months)
- HDL cholesterol(Baseline and 12 months)
- LDL cholesterol(Baseline and 12 months)
- Energy intake(Baseline, 3, 6, 9, and 12 months)
- Carbohydrate intake(Baseline, 3, 6, 9, and 12 months)
- HbA1c at 6 months(6 months)
研究者
Jonathan Little
Dr.
University of British Columbia