Effects of Tirzepatide on Gut Microbiota and the Recovery Pattern of Gastric Emptying After Drug Withdrawal in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in Gut Microbiota Characteristics
研究概览
简要总结
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.
详细描述
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. We will use 16S rRNA V3-V4 region sequencing to analyze microbial diversity and composition (Shannon, Simpson, Chao1 indices, PCoA, LEfSe). Furthermore, we 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal Weight Control (NW)
Healthy volunteers with normal weight. No intervention is administered. Blood and fecal samples are collected.
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.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Changes in Gut Microbiota Characteristics
时间窗: Baseline (0 week) and 3 months
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).
次要结局
- Changes in Metabolic Parameters(Baseline (0 week) and 3 months)
- Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦(Baseline (0 week) and 3 months)
- Change in Gastric Emptying Function(Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦)
研究者
ZongDan Jiang
Principal Investigator
Nanjing First Hospital, Nanjing Medical University