[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658135":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":39,"overallOfficials":24,"centralContacts":45,"locations":51,"responsibleParty":67,"collaborators":24,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":24,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":24,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":92,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in Gut Microbiota Characteristics","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",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Changes in Metabolic Parameters","Assessed by routine blood tests to evaluate metabolic improvement.",{"measure":18,"description":19,"timeFrame":12},"Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦","Assessed via GSRS questionnaire.",{"measure":21,"description":22,"timeFrame":23},"Change in Gastric Emptying Function","Measured by 13C-octanoic acid breath test.","Baseline, 3 months, and 1 week \u002F 1 month after drug withdrawal◦",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Obesity is a global public health crisis, and gut microbiota dysbiosis plays a crucial role in its pathophysiology. Tirzepatide, a dual GIP\u002FGLP-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.","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.",[31,34],{"label":32,"type":24,"description":33,"interventionNames":24},"Normal Weight Control (NW)","Healthy volunteers with normal weight. No intervention is administered. Blood and fecal samples are collected.",{"label":35,"type":24,"description":36,"interventionNames":37},"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.",[38],"Drug: Tirzepatide",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":24},"DRUG","Tirzepatide","Tirzepatide is administered as part of routine clinical care, not assigned by the investigator.",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"ZongDan Jiang","CONTACT","17590011635","alia_01@sina.com",[52],{"facility":53,"status":24,"city":54,"state":55,"zip":24,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Nanjing First Hospital","Nanjing","Jiangsu","China","CN",{"type":59,"coordinates":60},"Point",[61,62],118.77778,32.06167,{"lat":62,"lon":61},[65],{"name":47,"role":48,"phone":66,"phoneExt":24,"email":50},"+86-17590011635",{"type":68,"investigatorFullName":47,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100658135","effects-of-tirzepatide-on-gut-microbiota-and-gastrointestinal-function-after-drug-withdrawal-in-obese-patients-100658135",false,"NCT07847515","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","Inclusion Criteria:\n\nNormal Weight Control Group:\n\n* Age 18-65 years\n* 18.5 \\\u003C= BMI \\\u003C 24 kg\u002Fm2\n* No obesity-related complications\n* No diabetes, hypertension, or other metabolic diseases\n* No antibiotics, probiotics, or prebiotics in the past 3 months\n\nObese Treatment Group:\n\n* Age 18-65 years\n* BMI \\>= 30 kg\u002Fm2, or BMI \\>= 27 kg\u002Fm2 with at least one obesity-related complication\n* Physician-assessed indication for Tirzepatide\n* Planned initiation of Tirzepatide as part of routine clinical care\n* No antibiotics, probiotics, or prebiotics in the past 3 months\n\nExclusion Criteria:\n\n* Known inflammatory bowel disease (IBD), intestinal obstruction, or severe gastrointestinal disease\n* Gastrointestinal surgery within 6 months\n* Severe hepatic or renal impairment (ALT\u002FAST \\> 3x ULN, eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2)\n* History of malignancy\n* Severe psychiatric or cognitive disorder\n* Pregnancy or lactation\n* Acute infection within 1 month\n* Any condition deemed unsuitable by the investigator",true,"ALL","18 Years","65 Years",{"count":82,"type":83},80,"ESTIMATED","OBSERVATIONAL","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.",[87],"Obesity \u002F Overweight",[42,89,90,91],"Gut Microbiota","Obesity","Metabolic Improvement","NOT_YET_RECRUITING","2026-09-22",{"date":95,"type":96},"2026-09-29","ACTUAL",{"date":98,"type":83},"2027-02-01",{"date":100,"type":83},"2027-07-01",{"name":5,"class":6},1]