NCT06639425招募中不适用
Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes
Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c change
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).
详细描述
In this trial, approximately 60 drug-naive patients with newly diagnosed Type 2 Diabetes (T2D) will be recruited. Laboratory evaluations will be conducted on the subjects to confirm their eligibility before randomization. After the screening, eligible subjects will be randomly assigned in a 1:1 ratio to either the Lactobacillus paracasei LC19 supplementation group or the placebo group during the randomization visit. They will then enter a 12-week double-blind treatment period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, both genders eligible
- •Drug-naive patients with newly diagnosed type 2 diabetes
- •Subjects with screening HbA1c ≥ 7.0% and ≤ 9.0%
- •Subjects understand the nature, significance, potential benefits, inconvenience, and risks and procedure of the study, and voluntarily sign the informed consent form
排除标准
- •Other types of diabetes except T2D: type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing's syndrome, etc.)
- •Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 6 months
- •Subjects with history of hypoglycemia in the past 6 months
- •Subjects with history of New York Heart Association class (NYHA) grade of heart function ≥ III or serious cardiovascular diseases (myocardial infarction, or with the history of cardiac interventional therapy or stent implantation, valve disease or valve repair, unstable angina, transient ischemic attack or stroke) within 6 months before the screening period
- •Subjects with history of chronic active hepatitis and/or severe liver dysfunction, renal dysfunction, and thyroid dysfunction
- •Subjects with a medical history of malignant tumor
- •Subjects with history of gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.) or with a history of intestinal resection or other gastrointestinal surgery (such as cholecystectomy) within one year before the screening period
- •Subjects with history of surgery, or severe trauma in the past 6 months, or planning to undergo surgery during the study period
- •Subjects suffering from severe infections, severe anemia, or neutropenia
- •Subjects pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study period
- •Subjects with history of receiving immunosuppressants, steroids, anti diarrheal drugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motility medications within the past 3 months;
- •Subjects using other medications that can affect blood glucose in the past 3 months
- •Subjects with consumption of other probiotic or prebiotic products in the past 3 months before secreening
- •Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases
- •Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period
- •Subjects with history of mental illness or epilepsy, or taking antidepressant medications
- •Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40 grams per day and for women, exceeding 20 grams per day)
- •Subjects have participated in any other clinical study in the past 3 months
结局指标
主要结局
HbA1c change
时间窗: From enrollment to the end of treatment at 12 weeks
Changes in HbA1c from baseline at12 weeks during follow-up
次要结局
- fasting blood glucose change(From baseline at 4, 8, and 12 weeks during follow-up)
- Glycated albumin change(From baseline at 4 and 12 weeks during follow-up)
- Glycemic achieving rate(From enrollment to the end of treatment at 12 weeks)
- Glucose tolerance(From baseline at 4 and 12 weeks during follow-up)
- Insulin change(From baseline at 4 and 12 weeks during follow-up)
- Plasma GLP-1 change(From baseline at 4 and 12 weeks during follow-up)
- BMI change(From baseline at 4, 8, and 12 weeks during follow-up)
- Alteration of fecal metabolites(From enrollment to the end of treatment at 12 weeks)
- Alteration of gut microbiome(From enrollment to the end of treatment at 12 weeks)
研究者
Guang Wang
Director of Endocrinology
Beijing Chao Yang Hospital
研究点 (1)
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