An interventional study of Probiotics and Placebo in Gestational Diabetes, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Prevention
Risk of developing diabetes at a younger age among women with a previous history of gestational diabetes mellitus (post-GDM) has increased by 10-fold compared to the healthy women. However, consistent long-term lifestyle modifications by diet restriction and exercise are challenging. Interestingly, probiotics were found to balance gut bacteria and improve host metabolism. Thus, the aim of this study is to determine the beneficial roles of probiotics supplementation in post-GDM women.
Recent evidence highlighted disturbances in gut microbial compositions were associated with impairment of glucose and inflammation metabolism in women with GDM. Probiotics were hypothesized will modulate gut microbial compositions and maintain glucose and inflammation in the post-GDM women. This study aims to elucidate the roles of probiotic supplementation on metabolic and inflammatory outcomes in women with a previous history of gestational diabetes mellitus.
This is a 12-week randomized, double-blind, placebo-controlled, parallel-group clinical trial involving participants who had attended postnatal follow-up at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) with a recent history of GDM and had either postpartum glucose intolerance or overweight (body mass index (BMI) ≥23 kg/m2), or obese (BMI ≥27.5 kg/m2) during eligibility assessment.
A total of 166 post-GDM participants with either postpartum glucose intolerance or overweight/obese were randomly assigned to probiotics (n = 83) and placebo (n= 83) groups. Eligible participants were given probiotics supplementation consisting of 30 billion colony forming units (CFU) of six viable microorganisms from Lactobacillus and Bifidobacteria strains, twice daily for 12-week.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 166 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
83 participants received probiotics for 12-week
Dietary Supplement: Probiotics
83 participants received placebo for 12-week
Dietary Supplement: Placebo
Each sachet consists of 30 billion colony-forming units (CFU) of six viable probiotic strains (Lactobacillus acidophilus BCMC® 12130 (107 mg), Lactobacillus casei subsp. BCMC® 12313 (107 mg), Lactobacillus lactis BCMC® 12451 (107 mg), Bifidobacterium bifidum BCMC® 02290 (107 mg), Bifidobacterium infantis BCMC® 02129 (107 mg), and Bifidobacterium longum BCMC® 02120 (107 mg).
Also known as: HEXBIO® Microbial Cell Preparation (MCP)
Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.
Mean difference of fasting blood glucose (FBG)
Fasting blood glucose (FBG) levels were measured at the baseline and at the end of trial (post-12 weeks intervention). The mean difference of FBG was obtained by comparing the FBG levels at the end of trial with FBG levels at baseline. The mean difference of FBG levels were assessed within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of HbA1c
HbA1c levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of fasting serum insulin (FSI)
FSI levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of glucagon-like peptide -1 (GLP-1 active)
GLP-1 active levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of homeostasis model assessment of insulin resistance (HOMA-IR)
HOMA-IR levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of body mass index (BMI)
The detail for height was obtained from the antenatal record. The weight of participants at the baseline and the end of the trial (post-12 weeks intervention) was measured. BMI was calculated by dividing body weight (kg) with the square of the height (m2). BMI was compared within each intervention group and between the two intervention groups
Time frame: 12-week
Mean difference of waist circumference
Waist circumference at the baseline and the end of the trial (post-12 weeks intervention) was measured and compared within each intervention group and between the two intervention groups
Time frame: 12-week
Mean difference of blood pressure
Systolic and diastolic blood pressure at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups
Time frame: 12-week
Mean difference of total cholesterol and triglycerides
Total cholesterol and triglycerides levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of high sensitivity-C reactive protein (hs-CRP)
hs-CRP at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)
IL-1β, IL-6, and IL-8 levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)
Gut microbial composition, alpha diversity, beta diversity, and functional analysis at the baseline and at the end of trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
Time frame: 12-week
Plan to share: No
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National University of Malaysia