Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Change in gut microbiota
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with type 2 diabetes;
- •Taking ≤3 types of antidiabetic medications;
- •On a stable medication regimen for at least 6 weeks prior to the intervention and maintaining the same regimen during the study period;
- •Aged between 35 and 65 years;
- •Abdominal obesity: waist circumference >90 cm for men and >85 cm for women;
- •Body mass index (BMI) ≤35 kg/m²;
- •Waist-to-thigh ratio (WTR): ≥1.7 for men and ≥1.6 for women;
- •Sedentary lifestyle (engaging in moderate-intensity exercise for ≤60 minutes per week).
Exclusion Criteria
- •Glycated hemoglobin (HbA1c) <6.5% or ≥9%;
- •Use of insulin;
- •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);
- •History of cardiovascular events (e.g., myocardial infarction, stent implantation, unstable angina, heart failure, or cardiac dysfunction);
- •History of cerebrovascular disease (e.g., cerebral hemorrhage or ischemic stroke);
- •Muscular, skeletal, or neuromuscular injuries that hinder exercise training;
- •Severe osteoporosis or failure to meet bone mineral density criteria despite treatment;
- •Inability or unwillingness to undergo MRI examination (e.g., due to claustrophobia, implantable cardioverter-defibrillator [ICD], or pacemaker);
- •Diagnosed depression or any psychiatric disorder that prevents the patient from understanding the nature, scope, and possible sequence of the study;
- •Patients taking antihypertensive or lipid-lowering medications are excluded if their medication regimen is unstable or affects glucose metabolism.
Arms & Interventions
Exercise intervention group
Intervention: Exercise intervention (Behavioral)
Sedentary control group
Intervention: Sedentary behavior (Other)
Outcomes
Primary Outcomes
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
- Change in obesity-related anthropometrics(Baseline, 4, 8, 12, 16 weeks)
- Change in body mass index (BMI)(Baseline, 4, 8, 12, 16 weeks)
- Change in other indicators of glucose metabolism(Baseline, 4, 8, 12, and 16 weeks)
- Change in intrahepatic triglyceride content(Baseline, 16 weeks)
- Change in other indicators of lipid metabolism(Baseline, 4, 8, 12, and 16 weeks)
- Change in inflammatory markers(Baseline, 4, 8, 12, and 16 weeks)
- Change in liver function(Baseline, 4, 8, 12, and 16 weeks)
- Change in cytokines(Baseline, 16 weeks)
- Changes in body composition(Baseline and 16 weeks)
- Change in insulin sensitivity(Baseline and 16 weeks)
- Change in HbA1c(Baseline and 16 weeks)
Investigators
Li Huating
Professor
Shanghai 6th People's Hospital