Skip to main content
OpenTrials
Completed

NCT Number: NCT06931210

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-1. Diagnosed with type 2 diabetes; 2. Taking ≤3 types of antidiabetic medications; 3. On a stable medication regimen for at least 6 weeks prior to the intervention and maintaining the same regimen during the study period; 4. Aged between 35 and 65 years; 5. Abdominal obesity: waist circumference >90 cm for men and >85 cm for women; 6. Body mass index (BMI) ≤35 kg/m²; 7. Waist-to-thigh ratio (WTR): ≥1.7 for men and ≥1.6 for women; 8. Sedentary lifestyle (engaging in moderate-intensity exercise for ≤60 minutes per week).

Exclusion criteria

-1. Glycated hemoglobin (HbA1c) <6.5% or ≥9%; 2. Use of insulin; 3. Presence of one or more of the following complications: advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or renal dysfunction (estimated glomerular filtration rate [eGFR] ≤60 mL/min/1.73 m²); 4. History of cardiovascular events (e.g., myocardial infarction, stent implantation, unstable angina, heart failure, or cardiac dysfunction); 5. History of cerebrovascular disease (e.g., cerebral hemorrhage or ischemic stroke); 6. Muscular, skeletal, or neuromuscular injuries that hinder exercise training; 6. Severe osteoporosis or failure to meet bone mineral density criteria despite treatment; 7. Pregnancy; 8. Inability or unwillingness to undergo MRI examination (e.g., due to claustrophobia, implantable cardioverter-defibrillator [ICD], or pacemaker); 9. Diagnosed depression or any psychiatric disorder that prevents the patient from understanding the nature, scope, and possible sequence of the study; 10. Patients taking antihypertensive or lipid-lowering medications are excluded if their medication regimen is unstable or affects glucose metabolism.

Treatment and study plan

Sedentary behavior

Other

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

Exercise Intervention

Behavioral

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.

Primary outcomes

  1. Change in gut microbiota

    Time frame: Baseline and 16 weeks

    Gut microbiota, including microbial composition, diversity, functional metabolism, etc., will be measured at baseline and at 16 weeks using metagenomic sequencing and other related methods.

Secondary outcomes

  1. Changes in body composition

    Time frame: Baseline and 16 weeks

    The body composition parameters, including fat mass, changes in lean mass and its percentage, abdominal and thigh fat mass, as well as hip and lower limb muscle mass, etc., will be measured at baseline and after 16 weeks.

  2. Change in insulin sensitivity

    Time frame: Baseline and 16 weeks

    Insulin sensitivity will be assessed at baseline and 16 weeks.

  3. Change in HbA1c

    Time frame: Baseline and 16 weeks

    HbA1c will be measured at baseline and 16 weeks. HbA1c will be expressed in mmol/mol.

  4. Change in obesity-related anthropometrics

    Time frame: Baseline, 4, 8, 12, 16 weeks

    Obesity-related anthropometrics, including waist, hip, and thigh circumference, etc., will be assessed at baseline, 4, 8, 12, and 16 weeks.

  5. Change in body mass index (BMI)

    Time frame: Baseline, 4, 8, 12, 16 weeks

    Height, weight and BMI will be assessed at baseline, 4, 8, 12, and 16 weeks.

  6. Change in other indicators of glucose metabolism

    Time frame: Baseline, 4, 8, 12, and 16 weeks

    Other indicators of glucose metabolism, including blood glucose, insulin, C-peptide, and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

  7. Change in intrahepatic triglyceride content

    Time frame: Baseline, 16 weeks

    Intrahepatic triglyceride content will be assessed at baseline and 16 weeks.

  8. Change in other indicators of lipid metabolism

    Time frame: Baseline, 4, 8, 12, and 16 weeks

    Other indicators of lipid metabolism, including TC, TG, LDL-C, HDL-C and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

  9. Change in inflammatory markers

    Time frame: Baseline, 4, 8, 12, and 16 weeks

    Inflammatory markers, including CRP, serum amyloid A and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

  10. Change in liver function

    Time frame: Baseline, 4, 8, 12, and 16 weeks

    Liver function biomarkers, including ALT, AST and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

  11. Change in cytokines

    Time frame: Baseline, 16 weeks

    Cytokines, including FGF21, FGF19, FABP4, LCN2, adiponectin, and others, will be assessed at baseline and at 16 weeks.

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.