Effects of Chewing Gum on Glycaemic Control in Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- blood glucose measurements after with or without chewing
研究概览
简要总结
This study aims to assess the impact of enhanced chewing on glycaemic control in females with newly diagnosed GDM. It is hypothesised, that a fixed amount of gum chewed for 20 minutes before starting each meal could improve hyperglycaemia. The impact of chewing on postprandial capillary blood glucose (measured at one hour after breakfast, lunch and dinner) is determined as the primary outcome of this study.
Differences in fasting glucose and longitudinal changes over the study period should be additionally examined.
详细描述
Study design and participants This study is designed as an open-label, mono-centre randomized controlled trial with two parallel groups including a total of 74 female patients with recent diagnosis of GDM. Diagnosis of GDM is made in accordance with the IADPSG criteria between 24+0 and 27+6 weeks of gestation [IADPSG 2010]. All pregnant females (aged
between 18 and 45 years) will be recruited consecutively among women visiting our pregnancy outpatient department (Department of Obstetrics and Gynecology, Division of Obstetrics and fetomaternal Medicine, Medical University of Vienna).
Exclusion criteria
- Preconceptional overt diabetes (such as type 1 or type 2 diabetes)
- History of bariatric surgery or surgeries that induce malabsorption
- HIV- or hepatitis infection
- Decreased liver or kidney function (before pregnancy)
- history of malignant disorders
- Abuse of toxic substances
- Use of systemic steroids
- Multiple pregnancy
Treatment and Interventions Eligible patients are randomized to receive either routine care (control group) or routine care in addition to a chewing gum intervention for five days (beginning with the second study day, i.e. the day after baseline examination): sugar-free, fruit or mint flavoured gum chewed three times daily for 20 minutes before each meal. Routine care includes standard dietary and lifestyle advice for 30 minutes following our local recommendations as well as an advice on capillary blood glucose measurement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Preconceptional overt diabetes (such as type 1 or type 2 diabetes)
- •History of bariatric surgery or surgeries that induce malabsorption
- •HIV- or hepatitis infection
- •Decreased liver or kidney function (before pregnancy)
- •history of malignant disorders
- •Abuse of toxic substances
- •Use of systemic steroids
- •Active smoking status during pregnancy
- •Multiple pregnancy
- •Ovulatory drugs and in-vitro fertilisation
结局指标
主要结局
blood glucose measurements after with or without chewing
时间窗: for one week (7 Days) after breakfast, lunch and dinner
1hour postprandial capillary blood glucose measurements
次要结局
未报告次要终点
研究者
Christian Göbl
MD
Medical University of Vienna