NCT05541237招募中不适用
Type 2 Diabetes Intervention by Gut Microbiota-directed Diet -a Open Labelled Randomized Controlled Trials
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- changes of HbA1c compared with baseline
研究概览
简要总结
This study is a randomized, open labelled, placebo-controlled clinical trial. The main purpose is to verify the superior effect of gut microbiota directed diet intervention over standard diet intervention by evaluating the changes of HbA1c relative to baseline at 16 weeks and 28 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed type 2 diabetes mellitus patients who have been diagnosed or screened for treatment without any hypoglycemic drugs;
- •6.5%≤HbA1c≤8.5%；
- •FPG<10.0mmol/L;
排除标准
- •suspected other types of diabetes
- •Moderate stroke occurred within one year;
- •Frequent diarrhea or constipation in the past 3 months (more than 4 times / week);
- •Acute complications occurred in the past 3 months, such as infection, ketosis and acidosis;
- •Pregnant and lactating women (or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives);
- •Drinking (1 weeks of drinking more than 5 times, on average 2 two Baijiu or half Jin of yellow wine or 5 bottles of beer above);
- •Those who have received drug treatment for the following diseases in the past three months: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction;
- •Gastrointestinal surgery (except appendicitis and hernia surgery);
- •Antibiotics have been used in the past 3 months for 3 days or more;
- •Physical methods, such as liposuction or gastrointestinal reconstruction, have been used to lose weight in the past 3 months;
- •Physical disability, or inability to take care of themselves, recall and answer questions clearly due to other reasons;
- •Anemia: hemoglobin < 10g / dl;
- •Patients with severe liver diseases such as chronic hepatitis, persistent hepatitis and cirrhosis, and hepatitis B virus surface antigen (HBsAg) positive and abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value).
- •Other serious diseases, such as malignant tumors, serious mental diseases, serious infectious diseases, etc;
- •Patients who are participating in other intervention studies;
- •In the judgment of the study physician, there are any conditions that affect the study compliance, such as:Alcohol or drug abuse in the past 12 months; Serious adverse drug treatment compliance in the past 12 months; The residence is far away from the research center, or it is planned to move far away or travel frequently in the next year; The clinical diagnosis of dementia or the judgment of cognitive function by the research physician will affect the research compliance; Other medical, psychological or behavioral factors that affect the study compliance are judged by the study physician.
结局指标
主要结局
changes of HbA1c compared with baseline
时间窗: 28 weeks
changes of HbA1c compared with baseline
remission rate
时间窗: 28 weeks
remission rate of T2D by ADA guideline；ratio of subjects whose blood glucose can reach completely normal without drug intervention
次要结局
- control rate(at 16 weeks of treatment and 28 weeks of follow-up)
- blood lipid profile(at 16 weeks of treatment and 28 weeks of follow-up)
研究者
研究点 (1)
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