Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients

StatusNot Yet Recruiting
PhaseNot specified
Started

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Record History

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  1. Secondary endpoints revised (3)
    • Study description expanded, about 2 words
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07847515
Lead Sponsor Nanjing First Hospital, Nanjing Medical University
Conditions
(from sponsor)		 Obesity / Overweight
Related terms Obesity, Overweight
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov