Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Intense lifestyle overhaul shows promise for new diabetes patients

NCT ID NCT03839667

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

326 people

The number who actually took part.

Started

Jan 2019

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Life style are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Ruijin hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.