Clinical trial NCT06931210: Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes
Official title: Study of AI-based Prediction Models for Exercise-Induced Gut Microbiota Alterations in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in gut microbiota
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Changes in body composition
timeFrame: Baseline and 16 weeks
measure: Change in insulin sensitivity
timeFrame: Baseline and 16 weeks
measure: Change in HbA1c
timeFrame: Baseline and 16 weeks
measure: Change in obesity-related anthropometrics
timeFrame: Baseline, 4, 8, 12, 16 weeks
measure: Change in body mass index (BMI)
timeFrame: Baseline, 4, 8, 12, 16 weeks
measure: Change in other indicators of glucose metabolism
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change in intrahepatic triglyceride content
timeFrame: Baseline, 16 weeks
measure: Change in other indicators of lipid metabolism
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change in inflammatory markers
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change in liver function
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change in cytokines
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
References: