THE EFFECT OF FIBRE SUPPLEMENT ON GESTATIONAL DIABETES
Research type
Research Study
Full title
The use of soluble fibre for the prevention of gestational diabetes among high-risk women. A pilot study.
IRAS ID
230813
Contact name
Gary Frost
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 0 months, 29 days
Research summary
Gestational diabetes (diabetes developed during pregnancy) is a current Public Health issue, for its potential negative effects on both mother and baby.
In this study, we aim to evaluate the potential role of Guar gum (a fibre supplement) in the prevention of Gestational diabetes in women at high-risk. We also aim to evaluate Guar gum’s effect on blood sugar control in pregnant women who do develop diabetes during pregnancy.
Pregnant women at high-risk will undergo a routine test for diabetes before 16 weeks of pregnancy. After the test results we will have 2 groups of women: those who meet criteria for diabetes in pregnancy (Gestational diabetes) and those who do not have diabetes in that assessment.
Women without diabetes will be randomly assigned to either the “treatment group” (Guar gum fibre) or the placebo group (cellulose, a fibre with no potential benefits on blood sugar control). At 28 weeks of pregnancy a new test for diabetes will be performed. We will seek for differences in the incidence of Gestational diabetes between the treatment and placebo group.
Women with Gestational diabetes diagnosed at first assessment will also be randomly assigned to either the “treatment group” (Guar gum fibre) or the placebo group (cellulose, a fibre with no potential benefits on blood sugar control). In this group of women we will assess blood glucose control and need for insulin treatment through medical records.
The study will last approximately 12 weeks (from first assessment, usually at 14-16 weeks of pregnancy) to 28 weeks of pregnancy.REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/0255
Date of REC Opinion
21 Mar 2018
REC opinion
Further Information Favourable Opinion