Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Effects of Tirzepatide on Gut Microbiota and the Recovery Pattern of Gastric Emptying After Drug Withdrawal in Obese Patients
This is an observational cohort study. The primary objective is to analyze the dynamic changes in gut microbiota and metabolic profiles in obese patients treated with Tirzepatide. A total of 80 participants will be enrolled: 40 normal-weight controls (NW group) and 40 obese patients receiving Tirzepatide as part of their routine clinical care (OB-T group). Fecal samples for 16S rRNA sequencing and blood samples for metabolic markers will be collected at baseline and after 3 months. Changes in gut microbiota diversity and composition will be correlated with improvements in glucose and lipid metabolism. As per the approved protocol, exploratory follow-up assessments of gastrointestinal symptoms and gastric emptying parameters will also be conducted post-treatment.
研究概览
详细说明
Obesity is a global public health crisis, and gut microbiota dysbiosis plays a crucial role in its pathophysiology. Tirzepatide, a dual GIP/GLP-1 receptor agonist, has shown significant weight loss effects, but its impact on the human gut microbiome remains largely unexplored. This observational study aims to fill this gap by characterizing the longitudinal changes in gut microbiota in obese patients undergoing routine Tirzepatide treatment. The investigators will use 16S rRNA V3-V4 region sequencing to analyze microbial diversity and composition (Shannon, Simpson, Chao1 indices, PCoA, LEfSe). Furthermore, The investigators will explore the associations between these microbial shifts and improvements in glucose and lipid metabolism . As secondary and exploratory objectives, gastrointestinal symptoms (GSRS) and gastric emptying function (measured by 13C-octanoic acid breath test) will be monitored during the treatment and withdrawal phases to better understand the overall physiological impact of the treatment.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：ZongDan Jiang
- 电话号码：17590011635
- 邮箱：alia_01@sina.com
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国
- Nanjing First Hospital
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接触：
- ZongDan Jiang
- 电话号码：+86-17590011635
- 邮箱：alia_01@sina.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
A total of 80 participants will be enrolled at Nanjing First Hospital, including 40 normal-weight healthy controls and 40 obese patients receiving routine Tirzepatide treatment.
描述
Inclusion Criteria:
Normal Weight Control Group:
- Age 18-65 years
- 18.5 <= BMI < 24 kg/m2
- No obesity-related complications
- No diabetes, hypertension, or other metabolic diseases
- No antibiotics, probiotics, or prebiotics in the past 3 months
Obese Treatment Group:
- Age 18-65 years
- BMI >= 30 kg/m2, or BMI >= 27 kg/m2 with at least one obesity-related complication
- Physician-assessed indication for Tirzepatide
- Planned initiation of Tirzepatide as part of routine clinical care
- No antibiotics, probiotics, or prebiotics in the past 3 months
Exclusion Criteria:
- Known inflammatory bowel disease (IBD), intestinal obstruction, or severe gastrointestinal disease
- Gastrointestinal surgery within 6 months
- Severe hepatic or renal impairment (ALT/AST > 3x ULN, eGFR < 30 ml/min/1.73m2)
- History of malignancy
- Severe psychiatric or cognitive disorder
- Pregnancy or lactation
- Acute infection within 1 month
- Any condition deemed unsuitable by the investigator
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Normal Weight Control (NW)
Healthy volunteers with normal weight. No intervention is administered. Blood and fecal samples are collected. |
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Obese Treatment (OB-T)
Obese patients receiving Tirzepatide as part of their routine clinical care. The investigator only observes and collects blood and fecal samples. |
Tirzepatide is administered as part of routine clinical care, not assigned by the investigator. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Gut Microbiota Characteristics
大体时间：Baseline (0 week) and 3 months
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Assessed by 16S rRNA V3-V4 region sequencing. Includes Alpha diversity (Shannon, Simpson, Chao1), Beta diversity (PCoA), and core differential genera abundance (e.g., Akkermansia, Bacteroides). |
Baseline (0 week) and 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Fasting Plasma Glucose,, Lipid Profile, and Body Weight
大体时间：Baseline (0 week) and 3 months
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Assessed by routine fasting blood tests and anthropometric measurements. Metabolic markers include fasting plasma glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and body weight. |
Baseline (0 week) and 3 months
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Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦
大体时间：Baseline (0 week) and 3 months
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Assessed via the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. |
Baseline (0 week) and 3 months
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Change in Gastric Emptying Function
大体时间：Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
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Measured by 13C-octanoic acid breath test. |
Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KY20260430-05-KS-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data will not be shared due to participant privacy and ethical restrictions.
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