AI-based prediction models for gut microbiota changes in type 2 diabetes patients during exercise

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

This study is testing if a 16-week exercise program can change gut health in people with type 2 diabetes compared to those who don’t exercise.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 35 Years to 65 Years
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06931210 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized controlled intervention that aims to investigate the effects of combined aerobic and resistance exercise on gut microbiota alterations in patients with type 2 diabetes. Participants will be divided into two groups: one will engage in a structured exercise program over 16 weeks, while the other will maintain a sedentary lifestyle. The study will assess changes in gut microbiota, body composition, fatty liver severity, and glucose-lipid metabolism indicators. Additionally, it will validate a cross-species microbiota mapping model to understand the relationship between exercise and gut health in this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35 to 65 with type 2 diabetes, abdominal obesity, and a sedentary lifestyle.

Not a fit: Patients with well-controlled diabetes (HbA1c <6.5%) or severe complications such as advanced diabetic retinopathy or renal dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for type 2 diabetes through targeted exercise interventions that positively influence gut microbiota.

How similar studies have performed: While there is emerging interest in the relationship between exercise and gut microbiota, this specific approach using AI-based prediction models is relatively novel and has not been extensively tested.

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.

Where this trial is running

Shanghai

• Shanghai Sixth People's Hospital — Shanghai, China (Recruiting)

Conditions Type 2 Diabetes Mellitus