Intense lifestyle overhaul shows promise for new diabetes patients
NCT ID NCT03839667
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 12-week program of very-low-calorie diet or high-intensity exercise can improve blood sugar control in adults aged 40-70 who are newly diagnosed with type 2 diabetes and overweight. Participants are randomly assigned to diet, exercise, or standard education. The goal is to see if these intensive lifestyle changes are more effective than usual care for managing diabetes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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326 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
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Other studies related to the condition(s) this trial covers.
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