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Intensive Diet and Physical Activity on Diabetes (IDEATE)

Primary Purpose

Type2 Diabetes, Life Style

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intensive diet intervention
Enhanced physical activity intervention
Standard education
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

intensive diet intervention group

Enhanced physical activity group

Standard education group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

change in HbA1C level (%)

Secondary Outcome Measures

change in HbA1C level (%)
proportion of reversal of diabetes
reduction in the dosage of hypoglycemic drugs
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.
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).
change in liver steatosis quantified by MRI-PDFF (percentage)
change in body mass index (BMI)
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
change in visceral fat (cm^2)
change in serum fetuin-A concentration (μg/mL)
change in serum GREM2 concentration (pg/ml)
change in serum Caspase-cleaved Keratin 1 concentration (U/L)
changes in serum FGF21 concentration (pg/ml)
changes in overall gut microbiota profile
change in gut microbiota composition and proportion of specific gut flora.
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.
health related quality of life
Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
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.

Full Information

First Posted
January 6, 2019
Last Updated
December 22, 2022
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03839667
Brief Title
Intensive Diet and Physical Activity on Diabetes
Acronym
IDEATE
Official Title
Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Life Style

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive diet intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced physical activity group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard education group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
intensive diet intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced physical activity intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard education
Intervention Description
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 Measure Information:
Title
change in HbA1C level (%)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change in HbA1C level (%)
Time Frame
1 year
Title
proportion of reversal of diabetes
Time Frame
1 year
Title
reduction in the dosage of hypoglycemic drugs
Time Frame
1 year
Title
change in insulin sensitivity
Description
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.
Time Frame
1 year
Title
change in islet β-cell function
Description
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).
Time Frame
1 year
Title
change in liver steatosis quantified by MRI-PDFF (percentage)
Time Frame
1 year
Title
change in body mass index (BMI)
Description
Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
Time Frame
1 year
Title
change in visceral fat (cm^2)
Time Frame
1 year
Title
change in serum fetuin-A concentration (μg/mL)
Time Frame
1 year
Title
change in serum GREM2 concentration (pg/ml)
Time Frame
1 year
Title
change in serum Caspase-cleaved Keratin 1 concentration (U/L)
Time Frame
1 year
Title
changes in serum FGF21 concentration (pg/ml)
Time Frame
1 year
Title
changes in overall gut microbiota profile
Description
change in gut microbiota composition and proportion of specific gut flora.
Time Frame
1 year
Title
depression
Description
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.
Time Frame
1 year
Title
health related quality of life
Description
Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
Time Frame
1 year
Title
cardiovascular risk
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ning, MD, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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