Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education: A Randomized Controlled Trial Focusing on HbA1c and Glucose Variability in Patients With Type 2 Diabetes (The BCC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in mean amplitude of glycaemic excursions (MAGE)
研究概览
简要总结
The aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (BCC) to the routine outpatient nutritional education for adult patients with type 2 diabetes.
The study hypothesis is that training and education in the BCC concept will improve glycaemic control either by reducing HbA1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.
详细描述
The trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard medical and dietary care (control group) or 2) Structured training and education in the BCC concept in addition to standard medical and dietary care.
The primary objective is to evaluate the six months effect of structured training and education in the BCC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Diabetes duration; from >12 months
- •HbA1c between 53 and 97 mmol/mol
- •Diet or any glucose-lowering medication
- •Provided voluntary written informed consent
排除标准
- •Practicing carbohydrate counting, as judged by the investigator
- •Participated in a BCC group program within the last two years
- •Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
- •Use of open CGM
- •Use of a Free Libre device
- •Use of an automated bolus calculator for carbohydrate counting, as judged by the investigator
- •Gastroparesis
- •Pregnancy or breastfeeding, or plans of pregnancy within the study period
- •Uncontrolled medical issues, as judged by the investigator
- •Concomitant participation in other clinical studies
- •Unable to understand the informed consent and the study procedures
结局指标
主要结局
Change in mean amplitude of glycaemic excursions (MAGE)
时间窗: Baseline, 6 months
mmol/l
Change in HbA1c
时间窗: Baseline, 6 months
mmol/mol
次要结局
- Change in body weight(Baseline, 6 months, 12 months)
- Change in low-density lipoprotein cholesterol (LDL-C)(Baseline, 6 months, 12 months)
- Change in total cholesterol (TC)(Baseline, 6 months, 12 months)
- Change in diastolic blood pressure(Baseline, 6 months, 12 months)
- Change in systolic blood pressure(Baseline, 6 months, 12 months)
- Change in waist circumference(Baseline, 6 months, 12 months)
- Change in mathematical literacy(Baseline, 6 months, 12 months)
- Change in intake of dietary fibre(Baseline, 6 months)
- Change in HbA1c(12 months)
- Changes in time spent in hypoglycaemia (<3.9 mmol/l)(Baseline, 6 months)
- Change in dietary intake of carbohydrates(Baseline, 6 months)
- Change in dietary intake of monounsaturated fatty acids (MUFA)(Baseline, 6 months)
- Change in dietary intake of polyunsaturated fatty acids (PUFA)(Baseline, 6 months)
- Change in triglycerides (TG)(Baseline, 6 months, 12 months)
- Change in standard deviation of mean plasma glucose(Baseline, 6 months)
- Change in carbohydrate estimation accuracy(Baseline, 6 months, 12 months)
- Change in degree of autonomy-supportive dietitian(Baseline, 6 months, 12 months)
- Change in total energy intake(Baseline, 6 months)
- Change in high-density cholesterol (HDL-C)(Baseline, 6 months, 12 months)
- Change in free fatty acids (FFA)(Baseline, 6 months, 12 months)
- Change in hip circumference(Baseline, 6 months, 12 months)
- Change in total fat mass(Baseline, 6 months)
- Change in time in range (3.9-10.0 mmol/l)(Baseline, 6 months)
- Change time spent in hyperglycaemia (e.g. >11.1 mmol/l)(Baseline, 6 months)
- Change in perceived competences in diabetes(Baseline, 6 months, 12 months)
- Change in dietary intake of saturated fatty acids (SFA)(Baseline, 6 months)
- Change in total fat free mass(Baseline, 6 months)
- Change in diet-related quality of life(Baseline, 6 months, 12 months)
- Change in dietary intake of total fat(Baseline, 6 months)
- Change in dietary intake of protein(Baseline, 6 months)
- Change in dietary intake of added sugar(Baseline, 6 months)
研究者
Bettina Ewers
Head of nutrition, MSc
Steno Diabetes Center Copenhagen