Intensive Diet and Physical Activity on Diabetes

NCT ID: NCT03839667

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2022-03-21

Brief 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.

Conditions

Type2 Diabetes; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intensive diet intervention group

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.

Group Type: EXPERIMENTAL

intensive diet intervention

Intervention Type: BEHAVIORAL

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 group

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.

Group Type: EXPERIMENTAL

Enhanced physical activity intervention

Intervention Type: BEHAVIORAL

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 group

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.

Group Type: EXPERIMENTAL

Standard education

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Men and women aged 40-70 years;

2. Newly diagnosed type 2 diabetes

• Duration of type 2 diabetes ≤ 2 years;
• Antidiabetic treatment maintained for at least 6 weeks before recruitment;

3. 7.0%≤ HbA1c < 9.0%;

4. 25 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;

Exclusion Criteria

1. History consistent with type 1 diabetes;

2. Insulin treatment;

3. Severe cardiovascular disease:

• current angina
• myocardial infarction within last six months
• heart failure
• symptomatic periphery vascular disease

4. Uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg;

5. Myocardial ischemia indicated by resting ECG;

6. Foot ulcers, peripheral neuropathy or skeletal disorders;

7. Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase

8. Average weekly alcohol intake >140 grams for men and >70 grams for women;

9. ALT or AST levels more than twice the upper limit of the normal range or active liver diseases;

10. eGFR <60 ml/min/1.73 m2, or serum creatinine >1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria

11. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment

12. Hemoglobin concentration <130 g/l for men or <120 g/l for women;

13. Past or present confirmed psychiatric illness or drug dependence;

14. History of food allergies;

15. Surgical history of digestive system;

16. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);

17. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);

18. Known to have metabolism-affecting diseases;

19. Known to have infectious diseases within last month;

20. Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;

21. Other acute diseases supported by clinical evidence which may contradict to the interventions;

22. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;

23. Currently participating in another intervention study;

24. Failure to obtain informed consent from participant;

25. Any factors judged by the clinic team to be likely to limit adherence to interventions;

26. Any other medical condition judged by the clinic team not eligible for the trial.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guang Ning

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Ning, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Ruijin-2018-174-2

Identifier Type: -

Identifier Source: org_study_id