Type 2 DiabetesNCT05346250
Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects
An observational study of Type 2 Diabetes and Obesity, Abdominal, run by Shanghai Zhongshan Hospital.
Trial summary
Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity, Abdominal
- What is being tested?
- Moderate intensity exercise and Vigorous intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2011to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants in our study included all subjects who had been enrolled in the previous randomized controlled trial.
Who may be able to join
- Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
- 40-65 years old;
- Waist circumference >90cm for men and >85cm for women
Who cannot join
- Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;
- A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
- Myocardial infarction in the past six months;
- Biliary obstructive diseases;
- Uncontrolled hypertension (i.e. systolic BP>180 mmHg, and/or diastolic DBP >100 mmHg);
- Chronic kidney disease (serum creatinine ≥1.5 mg/dL in men and ≥1.3 mg/dL in women);
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- Heart failure (New York Heart Association III or IV);
- Currently participating in weight loss programs;
- Currently pregnant or planning to be pregnant;
- Having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism);
- Having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers);
- Unable to participate in the follow-up examination.
About this study
Official title: Effect of Moderate and Vigorous Exercise on Incident Diabetes in Central Obese Subjects: a 10-year Follow-up Study
Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.
Read the detailed description
Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.
- Conditions
- Type 2 Diabetes, Obesity, Abdominal
- Being tested
- Non-exercise control, Moderate intensity exercise, Vigorous intensity exercise
- Keywords
- Type 2 Diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-exercise controlBehavioural
12 month lifestyle education
Moderate intensity exerciseBehavioural
12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.
Vigorous intensity exerciseBehavioural
6 month vigorous intensity exercise on treadmill for 30 min per day and more than 5 days per week, and subsequent 6 month moderate exercise by brisk walk 30 min per day and more than 5 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Non exercise program | Subjects receive 12 month lifestyle education alone. Receives: Behavioral: Non-exercise control | |
| Moderate intensity exercise program | Subjects receive 12 month moderate exercise. Receives: Behavioral: Moderate intensity exercise | |
| Vigorous intensity exercise program | Subjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise Receives: Behavioral: Vigorous intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes
The occurrence of diabetes at 2- and 10-year follow-up
Measured: 10 years since randomization
Secondary outcomes (3)
Body weight change
Body weight change at 2 and 10 year follow-up
Measured: 10 years since randomization
Blood pressure change
Systolic and diastolic blood pressure at 2- and 10-year follow-up
Measured: 10 years since randomization
Serum lipid change
Serum triglyceride, LDL-c levels at 2- and 10- year follow-up
Measured: 10 years since randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jul 2011
- Primary completion15 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Li, Shanghai Zhongshan Hospital
- Investigators
- Xiaoying Li, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346250
- Sponsor's protocol ID
- CCEMD011V2
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified data will be available after approval of the proposal
Publications
Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.
PubMed 27379904Zhang HJ, Pan LL, Ma ZM, Chen Z, Huang ZF, Sun Q, Lu Y, Han CK, Lin MZ, Li XJ, Yang SY, Li XY. Long-term effect of exercise on improving fatty liver and cardiovascular risk factors in obese adults: A 1-year follow-up study. Diabetes Obes Metab. 2017 Feb;19(2):284-289. doi: 10.1111/dom.12809. Epub 2016 Nov 22.
PubMed 27761987Zhang HJ, Zhang XF, Ma ZM, Pan LL, Chen Z, Han HW, Han CK, Zhuang XJ, Lu Y, Li XJ, Yang SY, Li XY. Irisin is inversely associated with intrahepatic triglyceride contents in obese adults. J Hepatol. 2013 Sep;59(3):557-62. doi: 10.1016/j.jhep.2013.04.030. Epub 2013 May 9.
PubMed 23665283Chen Y, Chen Z, Pan L, Ma ZM, Zhang H, Li XJ, Li X. Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults With Obesity: A 10-Year Follow-up of a Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):272-275. doi: 10.1001/jamainternmed.2022.6291.
PubMed 36716009
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate and Vigorous Exercise on Incident Diabetes in Central Obese Subjects: a 10-year Follow-up Study
- ClinicalTrials.gov ID
- NCT05346250
- Acronym / sponsor ID
- CCEMD011V2
- Conditions
- Type 2 Diabetes, Obesity, Abdominal
- Keywords
- Type 2 Diabetes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. The purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. Those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.
Detailed description
Our previous randomized controlled trial has recruited 220 subject with central obesity and NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. The exercise intervention lasted one year. Those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. All the subjects will be invited to participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level and HbA1c were measured. The history of diabetes and anti-diabetic medication will be recorded. The incident diabetes will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non exercise program | – | Behavioral: Non-exercise controlSubjects receive 12 month lifestyle education alone. |
| Moderate intensity exercise program | – | Behavioral: Moderate intensity exerciseSubjects receive 12 month moderate exercise. |
| Vigorous intensity exercise program | – | Behavioral: Vigorous intensity exerciseSubjects receive 6 month vigorous exercise and subsequent 6 month moderate exercise |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants in our study included all subjects who had been enrolled in the previous randomized controlled trial.
Key inclusion criteria (3 listed)
- Subjects with NAFLD determined by 1H MRS (intrahepatic triglyceride content ≥5%);
- 40-65 years old;
- Waist circumference >90cm for men and >85cm for women
Key exclusion criteria (12 listed)
- Consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months;
- A history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis;
- Myocardial infarction in the past six months;
- Biliary obstructive diseases;
- Uncontrolled hypertension (i.e. systolic BP>180 mmHg, and/or diastolic DBP >100 mmHg);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-exercise control12 month lifestyle education | Behavioural | Non exercise program |
| Moderate intensity exercise12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week. | Behavioural | Moderate intensity exercise program |
| Vigorous intensity exercise6 month vigorous intensity exercise on treadmill for 30 min per day and more than 5 days per week, and subsequent 6 month moderate exercise by brisk walk 30 min per day and more than 5 days per week. | Behavioural | Vigorous intensity exercise program |
Primary outcome
Incidence of type 2 diabetes
Time frame: 10 years since randomization
The occurrence of diabetes at 2- and 10-year follow-up
3 secondary outcomes
Body weight change
Time frame: 10 years since randomization
Blood pressure change
Time frame: 10 years since randomization
Serum lipid change
Time frame: 10 years since randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Results publication: PubMed 27379904Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.
- Results publication: PubMed 27761987Zhang HJ, Pan LL, Ma ZM, Chen Z, Huang ZF, Sun Q, Lu Y, Han CK, Lin MZ, Li XJ, Yang SY, Li XY. Long-term effect of exercise on improving fatty liver and cardiovascular risk factors in obese adults: A 1-year follow-up study. Diabetes Obes Metab. 2017 Feb;19(2):284-289. doi: 10.1111/dom.12809. Epub 2016 Nov 22.
- Results publication: PubMed 23665283Zhang HJ, Zhang XF, Ma ZM, Pan LL, Chen Z, Han HW, Han CK, Zhuang XJ, Lu Y, Li XJ, Yang SY, Li XY. Irisin is inversely associated with intrahepatic triglyceride contents in obese adults. J Hepatol. 2013 Sep;59(3):557-62. doi: 10.1016/j.jhep.2013.04.030. Epub 2013 May 9.
- Derived from this study: PubMed 36716009Chen Y, Chen Z, Pan L, Ma ZM, Zhang H, Li XJ, Li X. Effect of Moderate and Vigorous Aerobic Exercise on Incident Diabetes in Adults With Obesity: A 10-Year Follow-up of a Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):272-275. doi: 10.1001/jamainternmed.2022.6291.
- Individual participant dataSharing planned: Yes. deidentified data will be available after approval of the proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoying Li, MD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Obesity, Abdominal, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 2 diabetes (time frame: 10 years since randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346250, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.