Intensive Diet and Physical Activity on Diabetes
Condition: Type2 Diabetes; Life Style
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): intensive diet intervention; Enhanced physical activity intervention; Standard education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment