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

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how exercise affects the gut microbiota—the community of microorganisms living in our intestines—of people with type 2 diabetes. Participants will be divided into two groups: one group will engage in a 16-week program of aerobic and resistance exercises, while the other group will continue their usual sedentary lifestyle without any changes. The study aims to see how these different activities influence the gut microbiota and other health markers, such as body weight and blood sugar levels, in those with type 2 diabetes.

To participate, individuals must be between 35 and 65 years old, diagnosed with type 2 diabetes, and have certain health measurements like abdominal obesity. They should also be taking a stable amount of diabetes medications. However, those with certain health issues, such as severe diabetes complications or heart conditions, will not be eligible. Participants can expect to undergo health assessments before and after the exercise program, and the findings may help understand how improving gut health through exercise can benefit people with diabetes.

Gender

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Eligibility criteria

• 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.