Effect of Fibre Supplements on Gestational Diabetes (GG-GDM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03547960|
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
- 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
- Insulin sensitivity [ Time Frame: 12 weeks ]Insulin sensitivity will be calculated using the Matsuda index
- 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).
- 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.
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
|Contact: Gary Frost, PhD||020 3313 email@example.com|
|Contact: Lilian Mendoza, MDfirstname.lastname@example.org|
|Imperial College NHS Trust||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Anne Dornhorst, PhD 020 3313 3380 email@example.com|
|Contact: Lilian Mendoza, MD 07483212333 firstname.lastname@example.org|
|Principal Investigator:||Gary Frost, PhD||Chair of Nutrition. Imperial College London|