NCT07323134尚未招募不适用
The Effect of Semaglutide on the Intestinal Flora in Obesity
Beijing Chao Yang Hospital0 个研究点目标入组 40 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- The composition of the gut microbiota changes relative to the baseline
研究概览
简要总结
For obese individuals, semaglutide treatment was adopted. By using multi-omics techniques such as fecal metagenomic sequencing and based on in vitro strain screening platforms, the effects and specific mechanisms of semaglutide on the intestinal flora of obese patients were clarified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years old;
- •BMI ≥ 30kg/m²;
- •At least one self-reported history of unsuccessful lifestyle weight loss;
- •Subjects who agree to participate in the project and sign the informed consent form.
排除标准
- •Weight changes within 3 months prior to screening (self-reported) >5%;
- •Having received any drug treatment for obesity within the three months prior to screening;
- •The application of hypoglycemic drugs within 3 months before screening, or HbA1c≥ 6.5%, or a history of type 1 or type 2 diabetes;
- •Participants who have received treatment with immunosuppressants, steroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering drugs and/or other gastrointestinal motility drugs within 3 months prior to screening;
- •Previously diagnosed overweight or obesity due to endocrine causes, such as Cushing's syndrome, etc;
- •Triglycerides ≥500mg/dL (5.65mmol/L) during screening;
- •It is known that there are clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), a history of gastrointestinal diseases and surgical history;
- •Abnormal thyroid function;
- •History of mental illness;
- •History of multiple endocrine tumors or medullary thyroid cancer, family history, or calcitonin ≥6pg/mL;
- •Abnormal liver function during screening, that is, alanine aminotransferase and/or aspartate aminotransferase > 3*ULN;
- •Abnormal renal function during screening, that is, the estimated glomerular filtration rate is less than 60mL/min/1.75m2;
- •History of cardiovascular diseases;
- •History of malignant tumors;
- •Pregnancy or lactation;
- •As determined by the researcher, there are other physical, psychological or other conditions that make one unsuitable to participate in the trial.
结局指标
主要结局
The composition of the gut microbiota changes relative to the baseline
时间窗: Baseline,4weeks,8weeks,12weeks
The changes in the composition of the gut microbiota in obese individuals after 12 weeks of semaglutide treatment relative to the baseline (baseline is defined as the composition of the gut microbiota at the time of enrollment), including alterations in gut microbiota abundance and Shannon diversity index (α -diversity), etc.
次要结局
未报告次要终点
研究者
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