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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: ZongDan Jiang
- Telefonnummer: 17590011635
- E-post: alia_01@sina.com
Studiesteder
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Jiangsu
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Nanjing, Jiangsu, Kina
- Nanjing First Hospital
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Ta kontakt med:
- ZongDan Jiang
- Telefonnummer: +86-17590011635
- E-post: alia_01@sina.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Tirzepatide is administered as part of routine clinical care, not assigned by the investigator. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Gut Microbiota Characteristics
Tidsramme: 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). |
Baseline (0 week) and 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in Fasting Plasma Glucose,, Lipid Profile, and Body Weight
Tidsramme: Baseline (0 week) and 3 months
|
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
|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score◦
Tidsramme: Baseline (0 week) and 3 months
|
Assessed via the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. |
Baseline (0 week) and 3 months
|
|
Change in Gastric Emptying Function
Tidsramme: Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
|
Measured by 13C-octanoic acid breath test. |
Baseline, 3 months, and 1 week / 1 month after drug withdrawal◦
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvektig
- Overvekt
- Aminosyrer, peptider og proteiner
- Proteiner
- Glukagonlignende peptid-1 reseptor
- Glukagonlignende peptidreseptorer
- Reseptorer, G-protein-koblet
- Reseptorer, celleoverflate
- Membranproteiner
- Reseptorer, gastrointestinal hormon
- Reseptorer, peptid
- Tirzepatid
Andre studie-ID-numre
- KY20260430-05-KS-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data will not be shared due to participant privacy and ethical restrictions.
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