Status:
COMPLETED
Intensive Diet and Physical Activity on Diabetes
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Type2 Diabetes
Life Style
Eligibility:
All Genders
40-70 years
Phase:
NA
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...
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 me...
Eligibility Criteria
Inclusion
- 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;
- 7.0%≤ HbA1c \< 9.0%;
- 25 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2;
Exclusion
- 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
- Hemoglobin concentration \<130 g/l for men or \<120 g/l for women;
- Past or present confirmed psychiatric illness or drug dependence;
- History of food allergies;
- Surgical history of digestive system;
- Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
- Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
- Known to have metabolism-affecting diseases;
- Known to have infectious diseases within last month;
- Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;
- Other acute diseases supported by clinical evidence which may contradict to the interventions;
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Currently participating in another intervention study;
- Failure to obtain informed consent from participant;
- Any factors judged by the clinic team to be likely to limit adherence to interventions;
- Any other medical condition judged by the clinic team not eligible for the trial.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT03839667
Start Date
January 7 2019
End Date
March 21 2022
Last Update
December 27 2022
Active Locations (1)
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1
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025