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Effect of Fibre Supplements on Gestational Diabetes (GG-GDM)

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ClinicalTrials.gov Identifier: NCT03547960
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

TITLE The use of soluble fibre for the prevention of gestational diabetes among high-risk women. A pilot study.

AIMS 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 to evaluate the effect of the soluble fibre supplement on glycaemic control in high-risk women who develop gestational diabetes in early pregnancy.

DESIGN We plan 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 We will be studying women with diagnosis of gestational diabetes in previous pregnancies, (considered as high-risk) aged >18 years.

ELIGIBILITY Women over 18 years old with a history of gestational diabetes in previous pregnancies will be eligible to apply to this study. After first assessment, eligible women will be split according to their glycaemic status in women with and without early gestational diabetes.

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.

OUTCOME MEASURES

In women with normal glucose tolerance at first assessment:

Primary outcome: Gestational diabetes (yes/no) at 28 weeks gestation. Secondary outcomes: Insulin sensitivity and insulin secretion at 28 weeks gestation.

In women with early gestational diabetes (diagnosed at first assessment):

Primary outcome: Glycaemic control assessed the need of insulin treatment (yes/no) Secondary outcomes: In women requiring insulin treatment: days-to-insulin and total daily insulin dose.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Dietary Supplement: Guar gum Dietary Supplement: Cellulose Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Use of Soluble Fibre for the Prevention of Gestational Diabetes Among High-risk Women. A Pilot Study.
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guar gum in women with early GDM
5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks
Dietary Supplement: Guar gum
Fibre supplement to be taken with each meal

Placebo Comparator: Control/Cellulose in women with early GDM
5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks
Dietary Supplement: Cellulose
Placebo. Fibre supplement to be taken with each meal




Primary Outcome Measures :
  1. Gestational diabetes [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 12 weeks ]
    Insulin sensitivity will be calculated using the Matsuda index

  2. Insulin secretion [ Time Frame: 12 weeks ]
    Insulin secretion will be assessed by the second-void fasting urinary C-peptide (as validated by McDonald et al).

  3. Glycemic control [ Time Frame: 12 weeks ]
    Glycemic control, in women with early gestational diabetes, will be assessed by use of insulin (yes/no), in women who require insulin days to insulin and total insulin dose will be documented.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547960


Contacts
Contact: Gary Frost, PhD 020 3313 8037 g.frost@imperial.ac.uk
Contact: Lilian Mendoza, MD 07483212333 l.mendoza-mathison@imperial.ac.uk

Locations
United Kingdom
Imperial College NHS Trust Recruiting
London, United Kingdom, W12 0NN
Contact: Anne Dornhorst, PhD    020 3313 3380    a.dornhorst@imperial.ac.uk   
Contact: Lilian Mendoza, MD    07483212333    l.mendoza-mathison@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary Frost, PhD Chair of Nutrition. Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03547960     History of Changes
Other Study ID Numbers: IRAS ID: 230813
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications