PreDiabetesNCT03240978
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
A study testing exercise intervention in people with PreDiabetes and Insulin Sensitivity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched groups including high intensity exercise, moderate intensity exercise, and non-exercise groups. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Insulin Sensitivity
- What is being tested?
- exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2016to Dec 2023
- Phase
- Interventional
- 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 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight/obese Chinese man (25 kg/m2<BMI<32.5 kg/m2) aged between 21 and 60 years old; prediabetes, impaired glucose tolerance (mean 2-h blood glucose ≥7.8 and ≤11.1 mmol/l after a 75-g oral glucose challenge) or impaired fasting glucose (mean fasting blood glucose ≥6.1 mmol/l and ≤7.0 mmol/l and HbA1c levels between 5.7% and 6.4%).
Who cannot join
- any neurological, musculoskeletal or cardio respiratory condition, which would put them at risk during exercise or inhibit their ability to adapt to an exercise program; any subject participated in a regular vigorous exercise and/or diet program more than 2 times per week in the 3 months prior to recruitment; any subject who is taking medicine, especially antibiotics in the past week prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Study for the Effects of Physical Exercise on the Prevention of Prediabetes in Overweight Chinese: Role of Gut Microbiota and Adipokines
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched groups including high intensity exercise, moderate intensity exercise, and non-exercise groups. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. The effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be evaluated.
Read the detailed description
60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2 <BMI < 32.5 kg/m2) and prediabetes will be recruited.The participants will be divided into three age-matched groups (n=20 in each group),including high intensity exercise, moderate intensity exercise, and non-exercise groups. The suitability of each participant for physical exercise will be assessed by an in-house exercise specialist, based on parameters of blood pressure, strength, cardiovascular fitness, balance, flexibility. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. Each session will comprise of warm-up, resistance and aerobic training components and a cool-down. The high intensity training (aerobic combined with strength training) will consist of six exercises of three sets each, with each exercise set at an intensity of 6 to 10 repetition maximum. Intensity, volume and exercise selection will be varied both within the week and over the 12 week program in a periodised system designed to maximize muscle hypertrophy and strength gain. Exercise intensity will be at 60 to 80% of estimated heart rate maximum. Moderate intensity training (Aerobic training) will be conducted on a variety of ergometers including treadmill, cycle, rowing and cross training machines. The non-exercise group (delayed group) will be used as placebo control, and will participate in the training group at the later stage.
- Conditions
- PreDiabetes, Insulin Sensitivity
- Being tested
- exercise intervention
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| High intensity intervention | Experimental | Exercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks. Receives: Behavioral: exercise intervention |
| Moderate intensity intervention | Experimental | Exercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks. Receives: Behavioral: exercise intervention |
| non-exercise group | No intervention | Participants will not receive any type of exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of fasting glucose
fasting glucose level
Measured: change from baseline fasting glucose level at 12 weeks
Secondary outcomes (2)
alterations of gut microbiome
advanced metagenomics to identify gut microbiota species altered by exercise training
Measured: before, 4 weeks and 12 weeks after exercise training
rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
Participants in the exercise arms are further classified into responders or non-responsders, depending on whether they could demonstrate a decrease of insulin resistance index (HOMA-IR) greater than 2-fold technical error, which is a threshold for true physiological adaptation. HOMA-IR is calculated using homeostasis model assessment methods, defined as fasting insulin (μU/mL)×fasting glucose (mmol/L)/22.5.
Measured: before and after 12 weeks after exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startSep 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimin Xu, Principal investigator, Department of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240978
- Sponsor's protocol ID
- UW-15370
- Status last verified
- May 2022
- First submitted
- 27 Jul 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Chen J, Ni Y, Liu Y, Gao X, Tse MA, Panagiotou G, Xu A. Exercise-changed gut mycobiome as a potential contributor to metabolic benefits in diabetes prevention: an integrative multi-omics study. Gut Microbes. 2024 Jan-Dec;16(1):2416928. doi: 10.1080/19490976.2024.2416928. Epub 2024 Oct 29.
PubMed 39473051Jin L, Geng L, Ying L, Shu L, Ye K, Yang R, Liu Y, Wang Y, Cai Y, Jiang X, Wang Q, Yan X, Liao B, Liu J, Duan F, Sweeney G, Woo CWH, Wang Y, Xia Z, Lian Q, Xu A. FGF21-Sirtuin 3 Axis Confers the Protective Effects of Exercise Against Diabetic Cardiomyopathy by Governing Mitochondrial Integrity. Circulation. 2022 Nov 15;146(20):1537-1557. doi: 10.1161/CIRCULATIONAHA.122.059631. Epub 2022 Sep 22.
PubMed 36134579Liu Y, Wang Y, Ni Y, Cheung CKY, Lam KSL, Wang Y, Xia Z, Ye D, Guo J, Tse MA, Panagiotou G, Xu A. Gut Microbiome Fermentation Determines the Efficacy of Exercise for Diabetes Prevention. Cell Metab. 2020 Jan 7;31(1):77-91.e5. doi: 10.1016/j.cmet.2019.11.001. Epub 2019 Nov 27.
PubMed 31786155
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study for the Effects of Physical Exercise on the Prevention of Prediabetes in Overweight Chinese: Role of Gut Microbiota and Adipokines
- ClinicalTrials.gov ID
- NCT03240978
- Acronym / sponsor ID
- UW-15370
- Conditions
- PreDiabetes, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Aug 2017 (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.
Overweight/obese Chinese and prediabetes will be recruited and divided into three age-matched groups including high intensity exercise, moderate intensity exercise, and non-exercise groups. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. The effects of exercise on glucose and lipid profiles, insulin sensitivity and adiposity will be evaluated.
Detailed description
60 Chinese men aged between 21 and 60 years old with overweight/obesity (25 kg/m2 <BMI < 32.5 kg/m2) and prediabetes will be recruited.The participants will be divided into three age-matched groups (n=20 in each group),including high intensity exercise, moderate intensity exercise, and non-exercise groups. The suitability of each participant for physical exercise will be assessed by an in-house exercise specialist, based on parameters of blood pressure, strength, cardiovascular fitness, balance, flexibility. The exercise program will consist of three sessions per week over the course of 12 weeks, under the supervision of our in-house exercise specialists and physiologists. Each session will comprise of warm-up, resistance and aerobic training components and a cool-down. The high intensity training (aerobic combined with strength training) will consist of six exercises of three sets each, with each exercise set at an intensity of 6 to 10 repetition maximum. Intensity, volume and exercise selection will be varied both within the week and over the 12 week program in a periodised system designed to maximize muscle hypertrophy and strength gain. Exercise intensity will be at 60 to 80% of estimated heart rate maximum. Moderate intensity training (Aerobic training) will be conducted on a variety of ergometers including treadmill, cycle, rowing and cross training machines. The non-exercise group (delayed group) will be used as placebo control, and will participate in the training group at the later stage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity intervention | Experimental | Behavioral: exercise interventionExercise intervention at 70 to 80% of estimated heart rate maximum for 12 weeks. |
| Moderate intensity intervention | Experimental | Behavioral: exercise interventionExercise intervention at 50 to 70% of estimated heart rate maximum for 12 weeks. |
| non-exercise group | No intervention | –Participants will not receive any type of exercise training. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- overweight/obese Chinese man (25 kg/m2<BMI<32.5 kg/m2) aged between 21 and 60 years old; prediabetes, impaired glucose tolerance (mean 2-h blood glucose ≥7.8 and ≤11.1 mmol/l after a 75-g oral glucose challenge) or impaired fasting glucose (mean fasting blood glucose ≥6.1 mmol/l and ≤7.0 mmol/l and HbA1c levels between 5.7% and 6.4%).
Key exclusion criteria (1 listed)
- any neurological, musculoskeletal or cardio respiratory condition, which would put them at risk during exercise or inhibit their ability to adapt to an exercise program; any subject participated in a regular vigorous exercise and/or diet program more than 2 times per week in the 3 months prior to recruitment; any subject who is taking medicine, especially antibiotics in the past week prior to study.
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 |
|---|---|---|
| exercise interventionA period of 12-week exercise intervention under the supervision of exercise specialists will be conducted. | Behavioural | High intensity intervention, Moderate intensity intervention |
Primary outcome
change of fasting glucose
Time frame: change from baseline fasting glucose level at 12 weeks
fasting glucose level
2 secondary outcomes
alterations of gut microbiome
Time frame: before, 4 weeks and 12 weeks after exercise training
rate of non-responsiveness in the alleviation of insulin resistance to exercise intervention
Time frame: before and after 12 weeks after exercise training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 39473051Wang Y, Chen J, Ni Y, Liu Y, Gao X, Tse MA, Panagiotou G, Xu A. Exercise-changed gut mycobiome as a potential contributor to metabolic benefits in diabetes prevention: an integrative multi-omics study. Gut Microbes. 2024 Jan-Dec;16(1):2416928. doi: 10.1080/19490976.2024.2416928. Epub 2024 Oct 29.
- Derived from this study: PubMed 36134579Jin L, Geng L, Ying L, Shu L, Ye K, Yang R, Liu Y, Wang Y, Cai Y, Jiang X, Wang Q, Yan X, Liao B, Liu J, Duan F, Sweeney G, Woo CWH, Wang Y, Xia Z, Lian Q, Xu A. FGF21-Sirtuin 3 Axis Confers the Protective Effects of Exercise Against Diabetic Cardiomyopathy by Governing Mitochondrial Integrity. Circulation. 2022 Nov 15;146(20):1537-1557. doi: 10.1161/CIRCULATIONAHA.122.059631. Epub 2022 Sep 22.
- Derived from this study: PubMed 31786155Liu Y, Wang Y, Ni Y, Cheung CKY, Lam KSL, Wang Y, Xia Z, Ye D, Guo J, Tse MA, Panagiotou G, Xu A. Gut Microbiome Fermentation Determines the Efficacy of Exercise for Diabetes Prevention. Cell Metab. 2020 Jan 7;31(1):77-91.e5. doi: 10.1016/j.cmet.2019.11.001. Epub 2019 Nov 27.
- Individual participant dataSharing planned: No
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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.
Aimin Xu principal investigator
Department of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention in people with PreDiabetes and Insulin Sensitivity, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
change of fasting glucose (time frame: change from baseline fasting glucose level at 12 weeks). 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 NCT03240978, which also lists 3 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 18 May 2022.