The Use of Soluble Fibre for the Prevention of Gestational Diabetes Among High-risk Women. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Numbers Diagnosed With Gestational Diabetes
研究概览
简要总结
The primary aim of this study is to evaluate the effect of a soluble fibre supplement in the development of gestational diabetes in women at high-risk. The secondary aim will be to evaluate the effect of the soluble fibre supplement on glycaemic control in high-risk women who develop gestational diabetes in early pregnancy.
DESIGN The study plans to conduct a randomised open label controlled study to evaluate the effect of the consumption of soluble fibre, from early to mid-pregnancy, on the incidence of gestational diabetes, insulin sensitivity, insulin secretion and metabolic control in GDM diagnosed participants.
POPULATION The study team will be studying women with diagnosis of gestational diabetes in previous pregnancies, (considered as high-risk) aged >18 years.
TREATMENT Participants in the treatment arms will be 5 gr of Guar gum fibre supplement with meals three times a day (total daily 15 g). Participants in the placebo arms will be taking 5 gr of Cellulose three times a day (total daily dose 15 g).
DURATION Participants will be involved for 12 weeks.
OUTCOMES Primary outcome: In women with 16-week negative OGTT, GDM at 28 weeks
详细描述
Aim: To evaluate the effect of a soluble fibre supplement in glucose metabolism in pregnant women at high risk of developing gestational diabetes.
Study methodology: 12 week randomised, placebo-controlled, single-blinded study.
Intervention: Women will first be categorised according to their glycaemic status into two groups: GDM and glucose tolerant women. Afterwards, each group will be randomised into two groups and given either
- Fibre supplement (Guar gum)
- Placebo (Cellulose) The participants will take the dietary supplement three times a day for 12 weeks. They will receive regular antenatal control according to NICE guidelines recommendations. Compliance will be addressed by weekly phone calls.
Number of volunteers: The number of participants will be arbitrarily define as no data of this type of intervention exists in this cohort. 60 participants will be recruited. Previous studies, outside pregnancy, have observed metabolic effects in samples of 15-40 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a history of GDM in previous pregnancies
- •Age ≥ 18 years
- •Singleton pregnancy
- •≤ 16 weeks gestation
排除标准
- •Women unable or unwilling to give consent
- •Pre-gestational diabetes or use of anti-diabetic medication in the first visit
- •Significant chronic medical conditions (cardiovascular, liver or kidney disease)
- •Women participating in other medical trial
- •Women who have undergone bariatric surgery
- •Women with milk allergy/intolerance
- •Women unable to speak/understand English
结局指标
主要结局
Numbers Diagnosed With Gestational Diabetes
时间窗: 12 weeks
An Oral glucose tolerance test will be performed. Gestational diabetes will be diagnosed if fasting plasma glucose \>=5.3 and or 120 min plasma glucose \>=7.8
次要结局
- Comparison of Insulin Secretion Between the 2 Experimental Groups (Guar and Cellulose)(12 weeks)
- Comparison of Insulin Sensitivity Between the 2 Experimental Groups (Gur and Cellulose Groups)(12 weeks)