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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06931210
• Lead Sponsor: Shanghai 6th People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-17
• Study Start: 2025-04-18
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08-05
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in gut microbiota	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 Outcome Measures

Name	Time	Method
Changes in body composition	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.
Change in insulin sensitivity	Baseline and 16 weeks	Insulin sensitivity will be assessed at baseline and 16 weeks.
Change in HbA1c	Baseline and 16 weeks	HbA1c will be measured at baseline and 16 weeks. HbA1c will be expressed in mmol/mol.
Change in obesity-related anthropometrics	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.
Change in body mass index (BMI)	Baseline, 4, 8, 12, 16 weeks	Height, weight and BMI will be assessed at baseline, 4, 8, 12, and 16 weeks.
Change in other indicators of glucose metabolism	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.
Change in intrahepatic triglyceride content	Baseline, 16 weeks	Intrahepatic triglyceride content will be assessed at baseline and 16 weeks.
Change in other indicators of lipid metabolism	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.
Change in inflammatory markers	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.
Change in liver function	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.
Change in cytokines	Baseline, 16 weeks	Cytokines, including FGF21, FGF19, FABP4, LCN2, adiponectin, and others, will be assessed at baseline and at 16 weeks.

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China