Type2 DiabetesIDEATENCT03839667
Intensive Diet and Physical Activity on Diabetes
A study testing intensive diet intervention, Enhanced physical activity intervention and Standard education in people with Type2 Diabetes and Life Style, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type2 Diabetes, Life Style
- What is being tested?
- intensive diet intervention, Enhanced physical activity intervention and Standard education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2019to 21 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- History consistent with type 1 diabetes;
- Insulin treatment;
- Severe cardiovascular disease:
- current angina
- myocardial infarction within last six months
- heart failure
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
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.
Read the 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 mellitus; BMI ≥25 kg/m2 and <40 kg/m2. Main exclusion criteria include known type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of HbA1c changes between intensive intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims:
- Recruit 324 study participants who meet the eligibility criteria and randomly assign 108 to the intensive diet intervention group, 108 to the enhanced physical activity intervention group and 108 to the standard education group for 12 weeks;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
- Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle;
- Disseminate the study findings to influence clinical practice and clinical guidelines.
The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.
After the 12-week intervention, participants will receive post-intervention follow-up visits at 24 weeks, 36 weeks, 48 weeks, and 5 years from the baseline enrollment.
- Conditions
- Type2 Diabetes, Life Style
- Being tested
- intensive diet intervention, Enhanced physical activity intervention, Standard education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive diet interventionBehavioural
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.
Enhanced physical activity interventionBehavioural
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.
Standard educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1C level (%)
Measured: 12 weeks
Secondary outcomes (16)
change in HbA1C level (%)
Measured: From enrollment to the end of follow-up at 5 years
proportion of reversal of diabetes
Measured: From enrollment to the end of follow-up at 5 years
reduction in the dosage of hypoglycemic drugs
Measured: From enrollment to the end of follow-up at 5 years
change in insulin sensitivity
Quantify by HOMA score, which is calculated multiplying fasting plasma insulin (FPI, mIU/L) by fasting plasma glucose (FPG, mmol/L), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5.
Measured: From enrollment to the end of follow-up at 5 years
change in islet β-cell function
Quantify by HOMA score, which is calculated with fasting plasma insulin (FPI, mIU/L) and fasting plasma glucose (FPG, mmol/L), i.e. HOMA-β = 20*FPI/(FPG-3.5).
Measured: From enrollment to the end of follow-up at 5 years
change in liver steatosis quantified by MRI-PDFF (percentage)
Measured: From enrollment to the end of follow-up at 5 years
change in body mass index (BMI)
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
Measured: From enrollment to the end of follow-up at 5 years
change in visceral fat (cm^2)
Measured: From enrollment to the end of follow-up at 5 years
change in serum fetuin-A concentration (μg/mL)
Measured: From enrollment to the end of follow-up at 5 years
change in serum GREM2 concentration (pg/ml)
Measured: From enrollment to the end of follow-up at 5 years
change in serum Caspase-cleaved Keratin 1 concentration (U/L)
Measured: From enrollment to the end of follow-up at 5 years
changes in serum FGF21 concentration (pg/ml)
Measured: From enrollment to the end of follow-up at 5 years
changes in overall gut microbiota profile
change in gut microbiota composition and proportion of specific gut flora.
Measured: From enrollment to the end of follow-up at 5 years
depression
Evaluated with PHQ-9 scores. The PHQ is 59-question instrument, referring to the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (Not at all) to "3" (nearly every day).The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression.
Measured: From enrollment to the end of follow-up at 5 years
health related quality of life
Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
Measured: From enrollment to the end of follow-up at 5 years
cardiovascular risk
Evaluated with Framingham Risk Scores. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Measured: From enrollment to the end of follow-up at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Jan 2019
- Primary completion17 Jun 2021
- Study completion21 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839667
- Sponsor's protocol ID
- Ruijin-2018-174-2
- Acronym
- IDEATE
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu X, Ding Y, Shao F, Cao Q, Jiang Y, Li X, Xu Y, Zhao Z, Xu M, Lu J, Wang T, Wang S, Lin H, Li J, Liu Y, Gao J, Ning G, Wang W, Wang B, Bi Y, Li M. Metabolomic signatures of hepatic steatosis reveal heterogeneity in cardiometabolic risk and responses to lifestyle interventions in type 2 diabetes: a post hoc analysis. Cardiovasc Diabetol. 2026 Apr 29;25(1):179. doi: 10.1186/s12933-026-03194-0.
PubMed 42057080
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
- ClinicalTrials.gov ID
- NCT03839667
- Acronym / sponsor ID
- IDEATE / Ruijin-2018-174-2
- Conditions
- Type2 Diabetes, Life Style
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 21 Mar 2026 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mellitus; BMI ≥25 kg/m2 and <40 kg/m2. Main exclusion criteria include known type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of HbA1c changes between intensive intervention and standard education groups at a 2-sided significance level of 0.05. To achieve the proposed study objectives, we plan to perform the following specific aims:
- Recruit 324 study participants who meet the eligibility criteria and randomly assign 108 to the intensive diet intervention group, 108 to the enhanced physical activity intervention group and 108 to the standard education group for 12 weeks;
- Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
- Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
- Perform strict quality control procedures for intervention and data collection;
- Conduct data analysis according to the intention-to-treat principle;
- Disseminate the study findings to influence clinical practice and clinical guidelines.
The results will be analyzed to examine the pan-omics changes after the interventions and clarify their predictive benefits on the effects of the interventions.
After the 12-week intervention, participants will receive post-intervention follow-up visits at 24 weeks, 36 weeks, 48 weeks, and 5 years from the baseline enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intensive diet intervention group | Experimental | Behavioral: intensive diet interventionThe 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. |
| Enhanced physical activity group | Experimental | Behavioral: Enhanced physical activity interventionthe 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. |
| Standard education group | Experimental | Behavioral: Standard educationthe 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 40-70 years;
- Newly diagnosed type 2 diabetes
- 7.0%≤ HbA1c < 9.0%;
- 25 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
Key exclusion criteria (30 listed)
- History consistent with type 1 diabetes;
- Insulin treatment;
- Severe cardiovascular disease:
- Uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg;
- Myocardial ischemia indicated by resting ECG;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive diet interventionthe 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. | Behavioural | intensive diet intervention group |
| Enhanced physical activity interventionthe 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. | Behavioural | Enhanced physical activity group |
| Standard educationthe 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. | Behavioural | Standard education group |
Primary outcome
change in HbA1C level (%)
Time frame: 12 weeks
16 secondary outcomes
change in HbA1C level (%)
Time frame: From enrollment to the end of follow-up at 5 years
proportion of reversal of diabetes
Time frame: From enrollment to the end of follow-up at 5 years
reduction in the dosage of hypoglycemic drugs
Time frame: From enrollment to the end of follow-up at 5 years
change in insulin sensitivity
Time frame: From enrollment to the end of follow-up at 5 years
change in islet β-cell function
Time frame: From enrollment to the end of follow-up at 5 years
change in liver steatosis quantified by MRI-PDFF (percentage)
Time frame: From enrollment to the end of follow-up at 5 years
change in body mass index (BMI)
Time frame: From enrollment to the end of follow-up at 5 years
change in visceral fat (cm^2)
Time frame: From enrollment to the end of follow-up at 5 years
change in serum fetuin-A concentration (μg/mL)
Time frame: From enrollment to the end of follow-up at 5 years
change in serum GREM2 concentration (pg/ml)
Time frame: From enrollment to the end of follow-up at 5 years
change in serum Caspase-cleaved Keratin 1 concentration (U/L)
Time frame: From enrollment to the end of follow-up at 5 years
changes in serum FGF21 concentration (pg/ml)
Time frame: From enrollment to the end of follow-up at 5 years
changes in overall gut microbiota profile
Time frame: From enrollment to the end of follow-up at 5 years
depression
Time frame: From enrollment to the end of follow-up at 5 years
health related quality of life
Time frame: From enrollment to the end of follow-up at 5 years
cardiovascular risk
Time frame: From enrollment to the end of follow-up at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 42057080Wu X, Ding Y, Shao F, Cao Q, Jiang Y, Li X, Xu Y, Zhao Z, Xu M, Lu J, Wang T, Wang S, Lin H, Li J, Liu Y, Gao J, Ning G, Wang W, Wang B, Bi Y, Li M. Metabolomic signatures of hepatic steatosis reveal heterogeneity in cardiometabolic risk and responses to lifestyle interventions in type 2 diabetes: a post hoc analysis. Cardiovasc Diabetol. 2026 Apr 29;25(1):179. doi: 10.1186/s12933-026-03194-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive diet intervention, Enhanced physical activity intervention and Standard education in people with Type2 Diabetes and Life Style, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in HbA1C level (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.