Roles of Probiotics on Gut Microbiata Composition and Metabolic Outcomes in Women With a Recent History of Gestational Diabetes Mellitus: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Mean difference of HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years.
- •Attended postnatal follow-up at Universiti Kebangsaan Medical Center (four to eight weeks postpartum).
- •Have a recent history of gestational diabetes mellitus.
- •Willing to participate in the study.
- •Had either postpartum glucose intolerance, overweight (BMI ≥23 kg/m2), or obese (BMI ≥27.5 kg/m2) during eligibility assessment.
排除标准
- •Postpartum fasting blood glucose (FBG) level >8.0 mmol/L, two-hour postprandial (2HPP) glucose level >12 mmol/L.
- •Symptomatic of hyperglycemia and started on hypoglycemic agent.
- •Have underlying medical illnesses and required regular medications (i.e., pre- pregnancy diabetes, hypertension, congestive heart failure, renal failure, liver cirrhosis, gastrointestinal diseases, autoimmune diseases, and cancer) before and during intervention.
- •Had taken antibiotics / regularly consumed food or supplements rich in prebiotics/probiotics/symbiotics less than 12-week before recruitment or during intervention.
结局指标
主要结局
Mean difference of HbA1c
时间窗: 12-week
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.
Mean difference of homeostasis model assessment of insulin resistance (HOMA-IR)
时间窗: 12-week
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.
Mean difference of fasting serum insulin (FSI)
时间窗: 12-week
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.
Mean difference of fasting blood glucose (FBG)
时间窗: 12-week
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.
Mean difference of glucagon-like peptide -1 (GLP-1 active)
时间窗: 12-week
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.
次要结局
- Mean difference of waist circumference(12-week)
- Mean difference of high sensitivity-C reactive protein (hs-CRP)(12-week)
- Mean difference of total cholesterol and triglycerides(12-week)
- Mean difference of body mass index (BMI)(12-week)
- Mean difference of blood pressure(12-week)
- Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)(12-week)
- Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)(12-week)
研究者
PROF DR RAJA AFFENDI RAJA ALI
Consultant Physician & Gastroenterologist
National University of Malaysia