Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects

Completed

• Conditions: Obesity, Abdominal; Type 2 Diabetes
• Interventions: Behavioral: Vigorous intensity exercise; Behavioral: Moderate intensity exercise; Behavioral: Non-exercise control

• Registration Number: NCT05346250
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Detailed Description

Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.

Study Timeline

• Study Start: 2011-07-01
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vigorous intensity exercise program	Vigorous intensity exercise	Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise
Moderate intensity exercise program	Moderate intensity exercise	Subjects receive 12 month moderate exercise.
Non exercise program	Non-exercise control	Subjects receive 12 month lifestyle education alone.

Primary Outcome Measures

Name	Time	Method
Incidence of type 2 diabetes	10 years since randomization	The occurrence of diabetes at 2- and 10-year follow-up

Secondary Outcome Measures

Name	Time	Method
Serum lipid change	10 years since randomization	Serum triglyceride, LDL-c levels at 2- and 10- year follow-up
Body weight change	10 years since randomization	Body weight change at 2 and 10 year follow-up
Blood pressure change	10 years since randomization	Systolic and diastolic blood pressure at 2- and 10-year follow-up