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Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes

NCT06931210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2025-09-10

No results posted yet for this study

Summary

This study is a randomized controlled clinical trial. The participants will be randomized into two groups in a 1:1 ratio: exercise intervention and sedentary control group. The participants (50 participants per group) will undergo a 16-week intervention. Participants in the control group will maintain their sedentary lifestyle unchanged, and the exercise intervention group will receive combined aerobic and resistance exercise training. This study aims to compare the changes in gut microbiota before and after exercise intervention in patients. It will validate and optimize a cross-species microbiota mapping model through an independent exercise intervention clinical trial. Additionally, it will comprehensively assess the effects of combined aerobic and resistance exercise on patients' body composition, the severity of fatty liver, and glucose-lipid metabolism indicators. The study will also analyze the correlation between dynamic changes in the gut microbiota and the improvement of clinical symptoms in patients with type 2 diabetes after exercise intervention, elucidating the regulatory mechanisms of microbiota remodeling in exercise-mediated metabolic benefits.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

OTHER

Sedentary behavior

Patients in the control group will maintain their sedentary lifestyle unchanged.

BEHAVIORAL

Exercise intervention

The intervention will include a combination of aerobic and resistance exercises, performed three times per week. Each session will last 80 minutes. Aerobic and resistance training will include cycling, chest press, rowing, abdominal and back muscle exercises, as well as leg strength training.

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2025-08-05
Completion
2025-08-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06931210 on ClinicalTrials.gov