Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensive Diet and Physical Activity on Diabetes (IDEATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03839667
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Life Style Behavioral: intensive diet intervention Behavioral: Enhanced physical activity intervention Behavioral: Standard education Not Applicable

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:

  1. 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;
  2. Employ a study-wide strategy to encourage standard of care for all participants for the treatment of type 2 diabetes and other metabolic disorders;
  3. Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial participants;
  4. Perform strict quality control procedures for intervention and data collection;
  5. Conduct data analysis according to the intention-to-treat principle;
  6. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intensive Diet Intervention and Enhanced Physical Activity on Blood Glucose Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: intensive diet intervention
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.
Behavioral: Enhanced physical activity intervention
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.
Behavioral: Standard education
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.




Primary Outcome Measures :
  1. change in HbA1C level (%) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. proportion of reversal of diabetes [ Time Frame: 1 year ]
  2. reduction in the dosage of hypoglycemic drugs [ Time Frame: 1 year ]
  3. change in insulin sensitivity [ Time Frame: 1 year ]
    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.

  4. change in islet β-cell function [ Time Frame: 1 year ]
    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).

  5. change in liver steatosis quantified by MRI-PDFF (percentage) [ Time Frame: 1 year ]
  6. change in pancreatic adipose content quantified by MRI-PDFF (percentage) [ Time Frame: 1 year ]
  7. change in body mass index (BMI) [ Time Frame: 1 year ]
    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2

  8. change in visceral fat (cm^2) [ Time Frame: 1 year ]
  9. change in serum fetuin-A concentration (μg/mL) [ Time Frame: 1 year ]
  10. change in serum GREM2 concentration (pg/ml) [ Time Frame: 1 year ]
  11. change in serum Caspase-cleaved Keratin 1 concentration (U/L) [ Time Frame: 1 year ]
  12. changes in serum FGF21 concentration (pg/ml) [ Time Frame: 1 year ]
  13. changes in overall gut microbiota profile [ Time Frame: 1 year ]
    change in gut microbiota composition and proportion of specific gut flora.

  14. depression [ Time Frame: 1 year ]
    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.

  15. health related quality of life [ Time Frame: 1 year ]
    Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire

  16. cardiovascular risk [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839667


Contacts
Layout table for location contacts
Contact: Mian Li, MD, PhD +86-13764580084 limian39@aliyun.com
Contact: Yufang Bi, MD, PhD +86-21-64370045 ext 663340 byf10784@rjh.com.cn

Locations
Layout table for location information
China, Shanghai
Ruijin hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, MD, PhD    +86-21-64370045 ext 665345    feifei1116@hotmail.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Guang Ning, MD, PhD Shanghai Jiao Tong University School of Medicine

Layout table for additonal information
Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03839667     History of Changes
Other Study ID Numbers: Ruijin-2018-174-2
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases