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

ConditionObesity / Overweight
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years

18.5 <= BMI < 24 kg/m2

No obesity-related complications

No diabetes, hypertension, or other metabolic diseases

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tirzepatide

    Drug

    Tirzepatide is administered as part of routine clinical care, not assigned by the investigator.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Normal Weight Control (NW)0 interventions
Group B: Obese Treatment (OB-T)1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (0 week) and 3 months

Secondary outcomes

1

Changes in Metabolic Parameters

Assessed by routine blood tests to evaluate metabolic improvement.

Time frame
Baseline (0 week) and 3 months
2

Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦

Assessed via GSRS questionnaire.

Time frame
Baseline (0 week) and 3 months
3

Change in Gastric Emptying Function

Measured by 13C-octanoic acid breath test.

Time frame
Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing First Hospital, Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: