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

Shanghai 6th People's Hospital79 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in gut microbiota

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.

Time frame: Baseline and 16 weeks

Secondary Outcomes

Changes in body composition

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.

Time frame: Baseline and 16 weeks

Change in insulin sensitivity

Insulin sensitivity will be assessed at baseline and 16 weeks.

Time frame: Baseline and 16 weeks

Change in HbA1c

HbA1c will be measured at baseline and 16 weeks. HbA1c will be expressed in mmol/mol.

Time frame: Baseline and 16 weeks

Change in obesity-related anthropometrics

Obesity-related anthropometrics, including waist, hip, and thigh circumference, etc., will be assessed at baseline, 4, 8, 12, and 16 weeks.

Time frame: Baseline, 4, 8, 12, 16 weeks

Change in body mass index (BMI)

Height, weight and BMI will be assessed at baseline, 4, 8, 12, and 16 weeks.

Time frame: Baseline, 4, 8, 12, 16 weeks

Change in other indicators of glucose metabolism

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.

Time frame: Baseline, 4, 8, 12, and 16 weeks

Change in intrahepatic triglyceride content

Intrahepatic triglyceride content will be assessed at baseline and 16 weeks.

Time frame: Baseline, 16 weeks

Change in other indicators of lipid metabolism

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.

Time frame: Baseline, 4, 8, 12, and 16 weeks

Change in inflammatory markers

Inflammatory markers, including CRP, serum amyloid A and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

Time frame: Baseline, 4, 8, 12, and 16 weeks

Change in liver function

Liver function biomarkers, including ALT, AST and other relevant parameters, will be assessed at baseline, 4, 8, 12, and 16 weeks.

Time frame: Baseline, 4, 8, 12, and 16 weeks

Change in cytokines

Cytokines, including FGF21, FGF19, FABP4, LCN2, adiponectin, and others, will be assessed at baseline and at 16 weeks.

Time frame: Baseline, 16 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes