- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919603
Impact of Exercise Intervention on the Phenome
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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;
- 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 (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yufang Bi, MD, PhD
- Phone Number: +862164370045
- Email: byf10784@rjh.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Not yet recruiting
- Shanghai Institute of Endocrine and Metabolic Diseases
-
Contact:
- Mian Li, MD,PhD
- Phone Number: +862164370045
- Email: limian39@aliyun.com
-
Principal Investigator:
- Yufang Bi, MD, PhD
-
Sub-Investigator:
- Mian Li, MD, PhD
-
-
Shanxi
-
Datong, Shanxi, China
- Recruiting
- The Third People's Hospital of Datong City
-
Contact:
- Yan Liu, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 18-65 years;
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;
- No insulin treatment;
- 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:
- Men and women aged 18-65 years;
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;
- No insulin treatment;
- 23 Kg/m2 ≤ Body mass index (BMI) <40 Kg/m2;
Exclusion Criteria:
Severe cardiovascular disease:
- current angina
- myocardial infarction or stroke within last six months
- heart failure (NYHA grading III~IV)
- symptomatic periphery vascular disease
- Uncontrolled hypertension: systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg;
- Myocardial ischemia indicated by resting ECG;
- Cardiac dysfunction indicated by Echocardiogram;
- Abnormal HS-TNT or NT-proBNP concentration;
- 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
- ALT or AST levels more than three times 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 macro albuminuria (urine albumin/creatinine>300mg/g)
- Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment
- Past or present confirmed psychiatric illness or drug dependence;
- 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;
- 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: 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.
|
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)>.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in liver steatosis quantified by MRI-PDFF (percentage)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in liver steatosis quantified by MRI-PDFF (percentage)
Time Frame: 1 year
|
1 year
|
|
Change in the level of fasting blood glucose (mmol/l)
Time Frame: 12 weeks and 1 year
|
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
|
12 weeks and 1 year
|
|
Change in the level of HbA1c (percentage)
Time Frame: 12 weeks and 1 year
|
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
|
12 weeks and 1 year
|
Change in waist circumstance (cm)
Time Frame: 12 weeks and 1 year
|
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
|
12 weeks and 1 year
|
Change in serum non-HDL-C level (mg/dl)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum total cholesterol level (mg/dl)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum VLDL-C level (mg/dl)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum LDL-C level (mg/dl)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum HDL-C level (mg/dl)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum ApoB level (mg/dl)
Time Frame: 12 weeks and 1 year
|
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
|
12 weeks and 1 year
|
Change in blood pressure (mmHg)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in heart rate
Time Frame: 12 weeks and 1 year
|
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.
|
12 weeks and 1 year
|
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).
|
12 weeks and 1 year
|
Change in serum fetuin-A concentration (μg/mL)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in serum GREM2 concentration (pg/ml)
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in gut hormones, monocyte subtypes and other serum biomarkers
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in metabolic molecules concentration
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
|
Change in microRNA concentration
Time Frame: 12 weeks and 1 year
|
12 weeks and 1 year
|
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Change in overall gut microbiota profile
Time Frame: 12 weeks and 1 year
|
change in gut microbiota composition and proportion of specific gut flora.
|
12 weeks and 1 year
|
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.
|
12 weeks and 1 year
|
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.
|
12 weeks and 1 year
|
Change in diet pattern
Time Frame: 12 weeks and 1 year
|
Evaluated with a semiquantitative food frequency questionnaire.
|
12 weeks and 1 year
|
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.
|
12 weeks and 1 year
|
Change in daily exercise
Time Frame: 12 weeks and 1 year
|
Evaluated with short form International Physical Activity Questionnaire (IPAQ).
|
12 weeks and 1 year
|
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.
|
12 weeks and 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 1.0/2020-07-29
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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