ITMCTR2100004341招募中1 期
Effect of Jianpi Qinghua Decoction on gut microbiota, intestinal permeability and glycolipid metabolism in newly diagnosed T2DM patients: study protocol for a randomized, double-blind, placebo-controlled clinical trial
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 30 至 70（—）
- 性别
- All
入选标准
- •1. Newly diagnosed T2D patients according to the 1999 World Health Organization criteria (FBG 7 mmol/l or greater and / or 2-h OGTT 11.1 mmol/l or greater) who had not previously received pharmacological treatment;
- •2. 6.5% <= HbA1c <= 10%; 7 <= FBG <= 13.0 mmol/L;
- •3. Age 30 - 70 years old;
- •4. Body mass index (BMI): 24.0 <= BMI <= 30.0 kg·m-2;
- •5. Individuals who have not participated in any clinical trials within 3 months before being selected;
- •6. No serious heart, liver, or kidney diseases;
- •7. Able to keep taking granules for 3 months.
排除标准
- •1 Impaired liver function defined as AST / ALT excessed the upper limit of the normal range by 2.5 times; Renal insufficiency defined as serum creatinine > 132µmol·L-1 or estimated glomerular filtration rate (eGFR) < 60mL (1.73 x min x m2)-1; mental illness; severe infection; severe anemia and neutral Neutropenia;
- •2. Severe heart diseases, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy. New York Heart Association (NYHA) cardiac function grade >= III;
- •3. Diabetes caused by type 1 diabetes, monogenic diabetes, pancreatic injury or other secondary diabetes (such as Cushings syndrome, thyroid abnormalities and acromegaly);
- •4. Treatment with anti-diabetic drugs including oral anti-diabetic drugs, GLP-1 agonists or insulin;
- •5. A history of acute diabetic complications within 3 months, including diabetic ketoacidosis or hyperosmolar hyperglycemia nonketotic coma;
- •6. Have used antibiotics, steroid hormones, cytokines that can stimulate the body's immune system, methotrexate and other immunosuppressants in the past three months; used topical antibiotics (such as mouthwash) in the past 7 days;
- •7. Taking weight-loss drugs; corticosteroids administered by oral, intramuscular, intravenous, parenteral or intraarticular within the past 3 months;
- •8. Gastrointestinal diseases which can cause accurate chronic diarrhea or severe constipation;
- •9. Serious diseases such as tumor, immune system, blood system and other diseases in the past 5 years;
- •10. The history of bowel resection or other gastrointestinal surgery (such as cholecystectomy) in the past 1 year, or other history of parenteral surgery in the past 6 months;
- •11. History of substance addiction and alcohol abuse;
- •12. Pregnancy (HCG-positive urine in women of reproductive period), breastfeeding;
- •13. From the researcher's point of view, any factors that may interfere with the experiment.
研究者
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