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出境医 / 临床实验 / Impact of Exercise Intervention on the Phenome

Impact of Exercise Intervention on the Phenome

Study Description
Brief Summary:
It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an 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 intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Physical Activity Behavioral: Enhanced physical activity intervention Behavioral: Standard education Not Applicable

Detailed Description:

The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes; no insulin treatment; BMI ≥23 kg/m2 and <40 kg/m2. Main exclusion criteria include severe cardiovascular diseases, uncontrolled hypertension, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 3.0% reduction of liver triglyceride level changes between intensive physical activity 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 270 study participants who meet the eligibility criteria, including 90 people with normal glucose metabolism, 90 pre-diabetes patients and 90 newly diagnosed type 2 diabetes patients, and randomly assign 135 to the enhanced physical activity intervention group and 135 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 Diabetes Cohorts in China
Estimated Study Start Date : June 15, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2023
Arms and Interventions
Arm Intervention/treatment
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 diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)>.
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 diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)

Outcome Measures
Primary Outcome Measures :
  1. Change in liver steatosis quantified by MRI-PDFF (percentage) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in liver steatosis quantified by MRI-PDFF (percentage) [ Time Frame: 1 year ]
  2. Change in the level of fasting blood glucose (mmol/l) [ Time Frame: 12 weeks and 1 year ]
  3. Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l) [ Time Frame: 12 weeks and 1 year ]
  4. Change in the level of HbA1c (percentage) [ Time Frame: 12 weeks and 1 year ]
  5. Change in body mass index (BMI) [ Time Frame: 12 weeks and 1 year ]
    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2

  6. Change in waist circumstance (cm) [ Time Frame: 12 weeks and 1 year ]
  7. Change in body fat level (%) [ Time Frame: 12 weeks and 1 year ]
    Quantified by bioelectrical impedance analysis in a human body composition analyzer

  8. Change in serum non-HDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  9. Change in serum total cholesterol level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  10. Change in serum VLDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  11. Change in serum LDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  12. Change in serum HDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  13. Change in serum ApoB level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  14. Change in basal metabolic rate (BMR) (Kcal) [ Time Frame: 12 weeks and 1 year ]
    Quantified by bioelectrical impedance analysis in a human body composition analyzer

  15. Change in blood pressure (mmHg) [ Time Frame: 12 weeks and 1 year ]
  16. Change in heart rate [ Time Frame: 12 weeks and 1 year ]
  17. Change in insulin sensitivity [ Time Frame: 12 weeks and 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.

  18. Change in islet β-cell function [ Time Frame: 12 weeks and 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).

  19. Change in serum fetuin-A concentration (μg/mL) [ Time Frame: 12 weeks and 1 year ]
  20. Change in serum GREM2 concentration (pg/ml) [ Time Frame: 12 weeks and 1 year ]
  21. Change in gut hormones, monocyte subtypes and other serum biomarkers [ Time Frame: 12 weeks and 1 year ]
  22. Change in metabolic molecules concentration [ Time Frame: 12 weeks and 1 year ]
  23. Change in microRNA concentration [ Time Frame: 12 weeks and 1 year ]
  24. Change in overall gut microbiota profile [ Time Frame: 12 weeks and 1 year ]
    change in gut microbiota composition and proportion of specific gut flora.

  25. Depression [ Time Frame: 12 weeks and 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.

  26. Health related quality of life [ Time Frame: 12 weeks and 1 year ]
    Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire. The SF-12 is 12-question instrument, covering the eight domains of health outcomes, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 48. A higher score indicates a better health state.

  27. Change in diet pattern [ Time Frame: 12 weeks and 1 year ]
    Evaluated with a semiquantitative food frequency questionnaire.

  28. Change in sleeping pattern [ Time Frame: 12 weeks and 1 year ]
    Evaluated with Pittsburgh Sleep Quality Index, PSQI. Scores range from 0 to 21. A higher score indicates a worse sleeping pattern.

  29. Change in daily exercise [ Time Frame: 12 weeks and 1 year ]
    Evaluated with short form International Physical Activity Questionnaire (IPAQ).

  30. Cardiovascular risk [ Time Frame: 12 weeks and 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged 18-65 years;
  2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes

    Normal glucose metabolism:

    • FBG<5.6mmol/L and
    • 2h-PG<7.8mmol/L and
    • HbA1c<5.7%;

    Pre-diabetes:

    • 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
    • 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
    • 5.7% ≤ HbA1c ≤ 6.4%;

    Newly diagnosed diabetes:

    o Duration of type 2 diabetes is less than 5 years;

  3. No insulin treatment;
  4. 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;

Exclusion Criteria:

Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No

Criteria: Inclusion Criteria:

  1. Men and women aged 18-65 years;
  2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes

    Normal glucose metabolism:

    • FBG<5.6mmol/L and
    • 2h-PG<7.8mmol/L and
    • HbA1c<5.7%;

    Pre-diabetes:

    • 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
    • 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
    • 5.7% ≤ HbA1c ≤ 6.4%;

    Newly diagnosed diabetes:

    o Duration of type 2 diabetes is less than 5 years;

  3. No insulin treatment;
  4. 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;

Exclusion Criteria:

  1. Severe cardiovascular disease:

    • current angina
    • myocardial infarction or stroke within last six months
    • heart failure (NYHA grading III~IV)
    • symptomatic periphery vascular disease
  2. Uncontrolled hypertension: systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg;
  3. Myocardial ischemia indicated by resting ECG;
  4. Cardiac dysfunction indicated by Echocardiogram;
  5. Abnormal HS-TNT or NT-proBNP concentration;
  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. ALT or AST levels more than three times the upper limit of the normal range or active liver diseases;
  9. eGFR <60 ml/min/1.73 m2, or serum creatinine >1.5 mg/dl for men or 1.3mg/dl for women; or macro albuminuria (urine albumin/creatinine>300mg/g)
  10. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
  11. Past or present confirmed psychiatric illness or drug dependence;
  12. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
  13. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
  14. Known to have metabolism-affecting diseases;
  15. Other acute diseases supported by clinical evidence which may contradict to the interventions;
  16. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
  17. Currently participating in another intervention study;
  18. Failure to obtain informed consent from participant;
  19. Any factors judged by the clinic team to be likely to limit adherence to interventions;
  20. Any other medical condition judged by the clinic team not eligible for the trial.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yufang Bi, MD, PhD +862164370045 byf10784@rjh.com.cn

Locations
Layout table for location information
China, Shanghai
Shanghai Institute of Endocrine and Metabolic Diseases Not yet recruiting
Shanghai, Shanghai, China, 200025
Contact: Mian Li, MD,PhD    +862164370045    limian39@aliyun.com   
Principal Investigator: Yufang Bi, MD, PhD         
Sub-Investigator: Mian Li, MD, PhD         
China, Shanxi
The Third People's Hospital of Datong City Recruiting
Datong, Shanxi, China
Contact: Yan Liu, MS         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Tracking Information
First Submitted Date  ICMJE April 22, 2021
First Posted Date  ICMJE June 9, 2021
Last Update Posted Date June 9, 2021
Estimated Study Start Date  ICMJE June 15, 2021
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
Change in liver steatosis quantified by MRI-PDFF (percentage) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • Change in liver steatosis quantified by MRI-PDFF (percentage) [ Time Frame: 1 year ]
  • Change in the level of fasting blood glucose (mmol/l) [ Time Frame: 12 weeks and 1 year ]
  • Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l) [ Time Frame: 12 weeks and 1 year ]
  • Change in the level of HbA1c (percentage) [ Time Frame: 12 weeks and 1 year ]
  • Change in body mass index (BMI) [ Time Frame: 12 weeks and 1 year ]
    Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
  • Change in waist circumstance (cm) [ Time Frame: 12 weeks and 1 year ]
  • Change in body fat level (%) [ Time Frame: 12 weeks and 1 year ]
    Quantified by bioelectrical impedance analysis in a human body composition analyzer
  • Change in serum non-HDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum total cholesterol level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum VLDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum LDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum HDL-C level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum ApoB level (mg/dl) [ Time Frame: 12 weeks and 1 year ]
  • Change in basal metabolic rate (BMR) (Kcal) [ Time Frame: 12 weeks and 1 year ]
    Quantified by bioelectrical impedance analysis in a human body composition analyzer
  • Change in blood pressure (mmHg) [ Time Frame: 12 weeks and 1 year ]
  • Change in heart rate [ Time Frame: 12 weeks and 1 year ]
  • Change in insulin sensitivity [ Time Frame: 12 weeks and 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.
  • Change in islet β-cell function [ Time Frame: 12 weeks and 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).
  • Change in serum fetuin-A concentration (μg/mL) [ Time Frame: 12 weeks and 1 year ]
  • Change in serum GREM2 concentration (pg/ml) [ Time Frame: 12 weeks and 1 year ]
  • Change in gut hormones, monocyte subtypes and other serum biomarkers [ Time Frame: 12 weeks and 1 year ]
  • Change in metabolic molecules concentration [ Time Frame: 12 weeks and 1 year ]
  • Change in microRNA concentration [ Time Frame: 12 weeks and 1 year ]
  • Change in overall gut microbiota profile [ Time Frame: 12 weeks and 1 year ]
    change in gut microbiota composition and proportion of specific gut flora.
  • Depression [ Time Frame: 12 weeks and 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.
  • Health related quality of life [ Time Frame: 12 weeks and 1 year ]
    Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire. The SF-12 is 12-question instrument, covering the eight domains of health outcomes, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 48. A higher score indicates a better health state.
  • Change in diet pattern [ Time Frame: 12 weeks and 1 year ]
    Evaluated with a semiquantitative food frequency questionnaire.
  • Change in sleeping pattern [ Time Frame: 12 weeks and 1 year ]
    Evaluated with Pittsburgh Sleep Quality Index, PSQI. Scores range from 0 to 21. A higher score indicates a worse sleeping pattern.
  • Change in daily exercise [ Time Frame: 12 weeks and 1 year ]
    Evaluated with short form International Physical Activity Questionnaire (IPAQ).
  • Cardiovascular risk [ Time Frame: 12 weeks and 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Exercise Intervention on the Phenome
Official Title  ICMJE Impact of Exercise Intervention on the Phenome (Metabolism and Predictive Complications) in Well Characterised Pre-diabetes and New Onset Type 2 Diabetes Cohorts in China
Brief Summary It is an open-label, parallel-group, randomized controlled clinical trial, which is designed to enroll people with different glucose metabolism status who are also overweight or obese, including people with normal glucose metabolism, pre-diabetes patients and newly diagnosed type 2 diabetes patients. The patients are randomized to an 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 intends to compare the influence of enhanced physical activity treatment with that of a standard education on liver steatosis, serum glucose and lipids level, insulin sensitivity, cardiovascular metabolic parameters, metabolic molecules, and gut microbiota profile et al.
Detailed Description

The trial will recruit 270 patients from 2 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged 18-65 years; with normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes; no insulin treatment; BMI ≥23 kg/m2 and <40 kg/m2. Main exclusion criteria include severe cardiovascular diseases, uncontrolled hypertension, and other serious illness. The proposed trial has 90% statistical power to detect an absolute 3.0% reduction of liver triglyceride level changes between intensive physical activity 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 270 study participants who meet the eligibility criteria, including 90 people with normal glucose metabolism, 90 pre-diabetes patients and 90 newly diagnosed type 2 diabetes patients, and randomly assign 135 to the enhanced physical activity intervention group and 135 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight and Obesity
  • Physical Activity
Intervention  ICMJE
  • 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.
  • 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 diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Enhanced physical activity intervention
  • 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 diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)>.
    Intervention: Behavioral: Standard education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2023
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women aged 18-65 years;
  2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes

    Normal glucose metabolism:

    • FBG<5.6mmol/L and
    • 2h-PG<7.8mmol/L and
    • HbA1c<5.7%;

    Pre-diabetes:

    • 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
    • 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
    • 5.7% ≤ HbA1c ≤ 6.4%;

    Newly diagnosed diabetes:

    o Duration of type 2 diabetes is less than 5 years;

  3. No insulin treatment;
  4. 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;

Exclusion Criteria:

Eligibility Minimum Age: 18 Years Maximum Age: 65 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No

Criteria: Inclusion Criteria:

  1. Men and women aged 18-65 years;
  2. Normal glucose metabolism or pre-diabetes or newly diagnosed type 2 diabetes

    Normal glucose metabolism:

    • FBG<5.6mmol/L and
    • 2h-PG<7.8mmol/L and
    • HbA1c<5.7%;

    Pre-diabetes:

    • 5.6mmol/L ≤ FBG ≤ 6.9mmol/L and/or
    • 7.8mmol/L ≤ 2h-PG ≤ 11.0mmol/L and/or
    • 5.7% ≤ HbA1c ≤ 6.4%;

    Newly diagnosed diabetes:

    o Duration of type 2 diabetes is less than 5 years;

  3. No insulin treatment;
  4. 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;

Exclusion Criteria:

  1. Severe cardiovascular disease:

    • current angina
    • myocardial infarction or stroke within last six months
    • heart failure (NYHA grading III~IV)
    • symptomatic periphery vascular disease
  2. Uncontrolled hypertension: systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg;
  3. Myocardial ischemia indicated by resting ECG;
  4. Cardiac dysfunction indicated by Echocardiogram;
  5. Abnormal HS-TNT or NT-proBNP concentration;
  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. ALT or AST levels more than three times the upper limit of the normal range or active liver diseases;
  9. eGFR <60 ml/min/1.73 m2, or serum creatinine >1.5 mg/dl for men or 1.3mg/dl for women; or macro albuminuria (urine albumin/creatinine>300mg/g)
  10. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
  11. Past or present confirmed psychiatric illness or drug dependence;
  12. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids);
  13. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders);
  14. Known to have metabolism-affecting diseases;
  15. Other acute diseases supported by clinical evidence which may contradict to the interventions;
  16. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control;
  17. Currently participating in another intervention study;
  18. Failure to obtain informed consent from participant;
  19. Any factors judged by the clinic team to be likely to limit adherence to interventions;
  20. Any other medical condition judged by the clinic team not eligible for the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yufang Bi, MD, PhD +862164370045 byf10784@rjh.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04919603
Other Study ID Numbers  ICMJE 1.0/2020-07-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guang Ning, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP