N/A
N=60
Effect of Fibre Supplements on Gestational Diabetes
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03547960 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Numbers Diagnosed With Gestational Diabetes — 7; 6 Participants — p=0.639
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guar gum (Dietary_supplement); Cellulose (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers Diagnosed With Gestational Diabetes |
7; 6 | 0.639 |
| SECONDARY Comparison of Insulin Sensitivity Between the 2 Experimental Groups (Gur and Cellulose Groups) |
269.7; 324.2 | — |
| SECONDARY Comparison of Insulin Secretion Between the 2 Experimental Groups (Guar and Cellulose) |
433.9; 479.8 | 0.564 |
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
Eligibility Criteria
Inclusion Criteria
- Women with a history of GDM in previous pregnancies
- Age ≥ 18 years
- Singleton pregnancy
- ≤ 16 weeks gestation
Exclusion Criteria:• 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
Data sourced from ClinicalTrials.gov (NCT03547960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.