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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Exercise intervention; Other: Sedentary behavior

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise intervention group	Behavioral: Exercise intervention; The intervention will include a combination of aerobic and resistance exercises, performed three times per week. Each session will last 80 minutes. Aerobic and resistance training will include cycling, chest press, rowing, abdominal and back muscle exercises, as well as leg strength training.
Other: Sedentary control group	Other: Sedentary behavior; Patients in the control group will maintain their sedentary lifestyle unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 16 weeks
Change in insulin sensitivity	Insulin sensitivity will be assessed at baseline and 16 weeks.	Baseline and 16 weeks
Change in HbA1c	HbA1c will be measured at baseline and 16 weeks. HbA1c will be expressed in mmol/mol.	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.	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.	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.	Baseline, 4, 8, 12, and 16 weeks
Change in intrahepatic triglyceride content	Intrahepatic triglyceride content will be assessed at baseline and 16 weeks.	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.	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.	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.	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.	Baseline, 16 weeks

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2025
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2025-KY-121(K)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No