At a glance
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The Use of Soluble Fibre for the Prevention of Gestational Diabetes Among High-risk Women. A Pilot Study.
In Brief
A clinical study evaluating Guar gum and Cellulose for Gestational Diabetes. Completed, enrolled 60 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
Fibre supplement to be taken with each meal
Placebo. Fibre supplement to be taken with each meal