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Effect of Fibre Supplements on Gestational Diabetes
NA trial testing Guar gum in Gestational Diabetes in 60 participants. Completed in 17 March 2021.
| Lead sponsor | Imperial College London |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 30 May 2018 |
| Primary completion | 17 March 2021 |
| Estimated completion | 17 March 2021 |
| Sites | 1 location across United Kingdom |
Imperial College London
18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Guar Gum | 7 | |
| Control/Cellulose | 6 |
Insulin sensitivity will be assessed using the Matsuda index (is an whole body insulin sensitivity index that reflects a composite estimate of hepatic and muscle insulin sensitivity) in line with the following modified Matsuda equation in which insulin is substituted by the serum concentration of C-peptide for estimation purposes. In the the above index scale a lower number indicates lower sensitivity. Equation: ISOGTTC-pep=500,000/√{\[FPGxFsC-pep\] x \[mean glucose x mean sC-pep during the OGTT\]} There is no maximum or minum
| Group | Value | 95% CI |
|---|---|---|
| Guar Gum | 269.7 | ± 141.6 |
| Control/Cellulose | 324.2 | ± 210.3 |
HOMA-IR is a model that uses the static concentrations of fasting glucose and insulin for determination of insulin resistance and pancreatic beta-cell function. In the the above model scale a lower number indicates lower secretion. The validity of HOMA-IR index is lower in patients with low body mass index (BMI), low-activity of beta cells and high levels of blood glucose Homa IR =fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. There is no maximum or minimum
| Group | Value | 95% CI |
|---|---|---|
| Guar Gum | 433.9 | ± 377.5 |
| Control/Cellulose | 479.8 | ± 508.8 |
Time frame: 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Guar Gum | Control/Cellulose |
|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT03547960 adverse events section.
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
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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