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Intensive Diet and Physical Activity on Diabetes
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
It is a multicenter, open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll newly diagnosed type 2 diabetes patients with overweight or obesity. The patients are randomized to an intensive diet intervention (intermittent very-low -calorie diet), 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 will test the primary hypothesis of whether an intensive lifestyle treatment (diet or physical activity) is more effective than a standard education in glycemic control. The secondary hypotheses are to compare the intensive lifestyle treatment with a standard education on adipose distribution, metabolic parameters, metabolic molecules, Framingham Risk Scores, and quality of life, et al.
Official title: Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
326
Start Date
2019-01-07
Completion Date
2026-03-21
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
intensive diet intervention
the participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.
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.
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 healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.
Locations (1)
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China