Intensive Diet and Physical Activity on Diabetes

NCT03839667 | Active Not Recruiting

• 1 other identifier: Ruijin-2018-174-2
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes; Life Style

Outcome Measures

Primary Outcomes (1)

• change in HbA1C level (%)

  12 weeks

Secondary Outcomes (16)

• change in HbA1C level (%)

  From enrollment to the end of follow-up at 5 years

• proportion of reversal of diabetes

  From enrollment to the end of follow-up at 5 years

• reduction in the dosage of hypoglycemic drugs

  From enrollment to the end of follow-up at 5 years

• change in insulin sensitivity

  From enrollment to the end of follow-up at 5 years

• change in islet β-cell function

  From enrollment to the end of follow-up at 5 years

Study Arms (3)

intensive diet intervention group

EXPERIMENTAL

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: intensive diet intervention

Enhanced physical activity group

EXPERIMENTAL

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: Enhanced physical activity intervention

Standard education group

EXPERIMENTAL

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.

Behavioral: Standard education

Interventions

intensive diet intervention 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.

intensive diet intervention group

Standard education 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.

Standard education group

Enhanced physical activity intervention 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.

Enhanced physical activity group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 40-70 years;
• Newly diagnosed type 2 diabetes
• Duration of type 2 diabetes ≤ 2 years;
• Antidiabetic treatment maintained for at least 6 weeks before recruitment;
• %≤ HbA1c \< 9.0%;
• Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;

You may not qualify if:

• History consistent with type 1 diabetes;
• Insulin treatment;
• Severe cardiovascular disease:
• current angina
• myocardial infarction within last six months
• heart failure
• symptomatic periphery vascular disease
• Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg;
• Myocardial ischemia indicated by resting ECG;
• Foot ulcers, peripheral neuropathy or skeletal disorders;
• Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase
• Average weekly alcohol intake \>140 grams for men and \>70 grams for women;
• ALT or AST levels more than twice the upper limit of the normal range or active liver diseases;
• eGFR \<60 ml/min/1.73 m2, or serum creatinine \>1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria
• Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Officials

• Guang Ning, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: February 15, 2019
• Study Start: January 7, 2019
• Primary Completion: June 17, 2021
• Study Completion: March 21, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)