The Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes in Greece. A Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Effects of probiotics supplementation on glycemic control (HbA1c)
研究概览
简要总结
The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients).
The main questions to answer are:
- Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months?
- Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months?
- Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative.
Participants will be adult individuals (>18 years old) with T2D, followed at the outpatient Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece, who will be randomized to receive either a probiotic dietary supplement or a matching placebo capsule, once a day. They will be followed every 3 months (as is customary for diabetic patients). They will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric changes (weight, waist circumference, and blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
详细描述
Eligible participants will be randomized using a computer generator (www.randomization.com), which randomizes each subject to a single treatment by using the method of randomly permuted blocks, to receive either a multi-strain probiotic supplement (in the form of a capsule [LactoLevure^R]) or a matching placebo capsule, once a day. The probiotic capsule contains the species: Lactobacillus Acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, Saccharomyces boulardii (in the following quantities of colony-forming units [CFU]: Lactobacillus Acidophilus 1.75x10^9 CFU, Lactobacillus plantarum 0.5x10^9 CFU, Bifidobacterium lactis 1.75x10^9 CFU, Saccharomyces boulardii 1.5x10^9 CFU). The capsules (probiotics brand name LactoLevure^R and placebo) are prepared and donated to the study personnel by an unrestricted research grant from Uni-Pharma Greece, the producer of LactoLevure^R (Uni-Pharma Pharmaceutical Laboratories S.A., Kifisia, Greece), who will have no other interference with the planning, the conduction, or the analysis of the results of the study. The probiotic and placebo capsules will have an identical appearance and packaging. Neither the participants nor the investigators will be aware of the treatment assignments in this double-blinded study. Additionally, participants will be asked not to change their diet and exercise habits and to refrain from consuming yoghurt or other similar dietary supplements during the study. Care will be taken not to change the other pharmaceutical medicines during the study (participants who will have to initiate insulin treatment will be excluded from further follow-up and analysis in the study).
Sample size calculation will be based on previous similar studies considering 80% power at α = 0.05 to detect a difference in metabolic indices. All participants will be given verbal and written information about the study and will sign an informed consent form according to the recommendations of the Declaration of Helsinki.
Participants will be seen every 3 months in the outpatient Diabetes center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece (as is customary for diabetic patients) and will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric variables changes (weight and waist circumference, blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned (using a computer generator [www.randomization.com\], which randomizes each subject to a single treatment using randomly permuted blocks) to receive probiotic or placebo treatment, blinded to participants, study investigators, and physicians caring for the patients.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2D diagnosis of >6 months' duration
- •Age 18-90 years
- •A body-mass index (BMI) >18.5 kg/m^2
- •HbA1c level >6 percent (%)
- •on stable antidiabetic medications (oral or injectable glucagon-like peptide 1 receptor agonists [GLP-1 RAs]) for 8 weeks before the screening
排除标准
- •Type 1 or other type of diabetes
- •Pregnancy or wishing to become pregnant during the study
- •End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases >3.5x above normal)
- •The use of other probiotic products or antibiotics over the previous 6 months
- •Participation in other clinical trials
- •Insulin administration
- •The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)
结局指标
主要结局
Effects of probiotics supplementation on glycemic control (HbA1c)
时间窗: 6 months
To measure the difference of the change from baseline in mean HbA1c (percentage points) between the intervention (probiotic) group and placebo, after 6 months
次要结局
- Effects of probiotics supplementation on fasting blood glucose (FBG)(6 months)
- Effects of probiotics supplementation on adiposity measures (BMI, Waist circumference)(6 months)
- Effects of probiotics supplementation on lipid parameters (Total cholesterol, Triglycerides, HDL-C, LDL-C)(6 months)
- Effects of probiotics supplementation on liver function tests (AST, ALT, γGT, Alkaline Phosphatase)(6 months)
- Effects of probiotics supplementation on changes in gut microbiota diversity (alpha- and beta-diversity)(6 months)
研究者
Konstantinos Makrilakis, MD
Professor of Internal Medicine
National and Kapodistrian University of Athens