Overweight and Obesity, Physical Activity
Conditions
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.
Interventions
BEHAVIORALEnhanced 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.
BEHAVIORALStandard 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)
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver steatosis quantified by MRI-PDFF (percentage) | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the level of fasting blood glucose (mmol/l) | 12 weeks and 1 year | — |
| Change in the level of plasma glucose of 2 hours post glucose-load (mmol/l) | 12 weeks and 1 year | — |
| Change in the level of HbA1c (percentage) | 12 weeks and 1 year | — |
| Change in body mass index (BMI) | 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) | 12 weeks and 1 year | — |
| Change in body fat level (%) | 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) | 12 weeks and 1 year | — |
| Change in serum total cholesterol level (mg/dl) | 12 weeks and 1 year | — |
| Change in serum VLDL-C level (mg/dl) | 12 weeks and 1 year | — |
| Change in serum LDL-C level (mg/dl) | 12 weeks and 1 year | — |
| Change in serum HDL-C level (mg/dl) | 12 weeks and 1 year | — |
| Change in serum ApoB level (mg/dl) | 12 weeks and 1 year | — |
| Change in basal metabolic rate (BMR) (Kcal) | 12 weeks and 1 year | Quantified by bioelectrical impedance analysis in a human body composition analyzer |
| Change in blood pressure (mmHg) | 12 weeks and 1 year | — |
| Change in liver steatosis quantified by MRI-PDFF (percentage) | 1 year | — |
| Change in insulin sensitivity | 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 | 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) | 12 weeks and 1 year | — |
| Change in serum GREM2 concentration (pg/ml) | 12 weeks and 1 year | — |
| Change in gut hormones, monocyte subtypes and other serum biomarkers | 12 weeks and 1 year | — |
| Change in metabolic molecules concentration | 12 weeks and 1 year | — |
| Change in microRNA concentration | 12 weeks and 1 year | — |
| Change in overall gut microbiota profile | 12 weeks and 1 year | change in gut microbiota composition and proportion of specific gut flora. |
| Depression | 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 | 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 | 12 weeks and 1 year | Evaluated with a semiquantitative food frequency questionnaire. |
| Change in sleeping pattern | 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 | 12 weeks and 1 year | Evaluated with short form International Physical Activity Questionnaire (IPAQ). |
| Cardiovascular risk | 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. |
| Change in heart rate | 12 weeks and 1 year | — |
Countries
China
Contacts
Primary ContactYufang Bi, MD, PhD
Outcome results
None listed