CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Guar gum +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547960
NCT03547960N/ACompleted

The Use of Soluble Fibre for the Prevention of Gestational Diabetes Among High-risk Women. A Pilot Study.

Imperial College London·interventional·Posted Jun 6, 2018·Updated Dec 6, 2024

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartMay 30, 2018
Primary CompletionMar 17, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.1 years ago

Interventions

Guar gumdietary

Fibre supplement to be taken with each meal

Cellulosedietary

Placebo. Fibre supplement to be taken with each meal