NCT04919603

Impact of Exercise Intervention on the Phenome

Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 Diabetes Cohorts in China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an enhanced physical activity intervention (high-intensity interval training exercise prescription combined with resistance training) or standard education group (diabetes health education only, including lifestyle education and guidance) for 12 weeks. This trial intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.

Detailed description

The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes; no insulin treatment; BMI ≥23 kg/m2 and \<40 kg/m2. Main exclusion criteria include severe cardiovascular diseases, uncontrolled hypertension, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 3.0% reduction of liver triglyceride level changes between intensive physical activity intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims: 1. Recruit 270 study participants who meet the eligibility criteria, including 90 people with normal glucose metabolism, 90 pre-diabetes patients and 90 newly diagnosed type 2 diabetes patients, and randomly assign 135 to the enhanced physical activity intervention group and 135 to the standard education group for 12 weeks; 2. Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders; 3. Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants; 4. Perform strict quality control procedures for intervention and data collection; 5. Conduct data analysis according to the intention-to-treat principle; 6. Disseminate the study findings to influence clinical practice and clinical guidelines. The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.

Conditions

• Overweight and Obesity
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced physical activity intervention	the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
BEHAVIORAL	Standard education	the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to \< Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)

Timeline

• Start date: 2021-06-15
• Primary completion: 2022-05-30
• Completion: 2023-05-30
• First posted: 2021-06-09
• Last updated: 2021-06-09

Locations

2 sites across 1 country: China