NCT03839667

Intensive Diet and Physical Activity on Diabetes

Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial will recruit 324 patients from 2-3 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 40-70 years; newly-diagnosed type 2 diabetes mellitus; BMI ≥25 kg/m2 and \<40 kg/m2. Main exclusion criteria include known type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of HbA1c changes between intensive 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 324 study participants who meet the eligibility criteria and randomly assign 108 to the intensive diet intervention group, 108 to the enhanced physical activity intervention group and 108 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. After the 12-week intervention, participants will receive post-intervention follow-up visits at 24 weeks, 36 weeks, 48 weeks, and 5 years from the baseline enrollment.

Conditions

• Type2 Diabetes
• Life Style

Interventions

Type	Name	Description
BEHAVIORAL	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.
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 healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.

Timeline

• Start date: 2019-01-07
• Primary completion: 2021-06-17
• Completion: 2026-03-21
• First posted: 2019-02-15
• Last updated: 2026-02-12

Locations

1 site across 1 country: China