NCT03839667Active, not recruiting
Intensive Diet and Physical Activity on Diabetes
Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 326 (actual)
- First submitted
- 6 Jan 2019
- Start date
- 7 Jan 2019
- Primary completion date
- 17 Jun 2021
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Type 2 diabetes
- NCT number
- NCT03839667
What you commit to
- Study type: Interventional
- Participants enrolled: 326
- From 7 Jan 2019 to the primary completion date, 17 Jun 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
Other illness
- History consistent with type 1 diabetes;
- 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;
- Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
- Past or present confirmed psychiatric illness or drug dependence;
- History of food allergies;
- Surgical history of digestive system;
- Known to have metabolism-affecting diseases;
- Known to have infectious diseases within last month;
- Other acute diseases supported by clinical evidence which may contradict to the interventions;
- Failure to obtain informed consent from participant;
- Any other medical condition judged by the clinic team not eligible for the trial.
Lab values
- 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
- Hemoglobin concentration \<130 g/l for men or \<120 g/l for women;
- Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
- Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months;
Other
- Insulin treatment;
- 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;
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
- Currently participating in another intervention study;
- Any factors judged by the clinic team to be likely to limit adherence to interventions;
Who the study is looking for
- 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;
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.