- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839667
Intensive Diet and Physical Activity on Diabetes (IDEATE)
Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intensive diet intervention group
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.
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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.
|
Experimental: Enhanced physical activity group
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.
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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.
|
Experimental: Standard education group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in HbA1C level (%)
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in HbA1C level (%)
Time Frame: 1 year
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1 year
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proportion of reversal of diabetes
Time Frame: 1 year
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1 year
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reduction in the dosage of hypoglycemic drugs
Time Frame: 1 year
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1 year
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change in insulin sensitivity
Time Frame: 1 year
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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.
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1 year
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change in islet β-cell function
Time Frame: 1 year
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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).
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1 year
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change in liver steatosis quantified by MRI-PDFF (percentage)
Time Frame: 1 year
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1 year
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change in body mass index (BMI)
Time Frame: 1 year
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Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
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1 year
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change in visceral fat (cm^2)
Time Frame: 1 year
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1 year
|
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change in serum fetuin-A concentration (μg/mL)
Time Frame: 1 year
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1 year
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change in serum GREM2 concentration (pg/ml)
Time Frame: 1 year
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1 year
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change in serum Caspase-cleaved Keratin 1 concentration (U/L)
Time Frame: 1 year
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1 year
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changes in serum FGF21 concentration (pg/ml)
Time Frame: 1 year
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1 year
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changes in overall gut microbiota profile
Time Frame: 1 year
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change in gut microbiota composition and proportion of specific gut flora.
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1 year
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depression
Time Frame: 1 year
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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.
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1 year
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health related quality of life
Time Frame: 1 year
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Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
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1 year
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cardiovascular risk
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Guang Ning, MD, PhD, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ruijin-2018-174-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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