Effect of Fibre Supplements on Gestational Diabetes

NCT03547960 | Completed Results

• 1 other identifier: IRAS ID: 230813
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gestational Diabetes

Keywords

Gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Numbers Diagnosed With Gestational Diabetes

  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

  12 weeks

Secondary Outcomes (2)

• Comparison of Insulin Sensitivity Between the 2 Experimental Groups (Gur and Cellulose Groups)

  12 weeks

• Comparison of Insulin Secretion Between the 2 Experimental Groups (Guar and Cellulose)

  12 weeks

Study Arms (2)

Guar gum (intervention)

EXPERIMENTAL

5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks

Dietary Supplement: Guar gum

Control/Cellulose

PLACEBO COMPARATOR

5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks

Dietary Supplement: Cellulose

Interventions

Guar gum DIETARY_SUPPLEMENT

Fibre supplement to be taken with each meal

Guar gum (intervention)

Cellulose DIETARY_SUPPLEMENT

Placebo. Fibre supplement to be taken with each meal

Control/Cellulose

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a history of GDM in previous pregnancies
• Age ≥ 18 years
• Singleton pregnancy
• ≤ 16 weeks gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College NHS Trust

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

guar gum; Cellulose

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Recruitment was difficult during the COVID period We have a high dropout rate. Women diagnosed with early GDM abandoned the study after diagnosis and withdrew consent so their data is not analysed

Results Point of Contact

• Title: Gary Frost
• Organization: Imperial College London

g.frost@imperial.ac.uk

2075940959

Study Officials

• Gary Frost, PhD

  Chair of Nutrition. Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label controlled study

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 6, 2018
• Study Start: May 30, 2018
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)