Prediabetic StateNCT02561377
Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)
A study testing resistance training and aerobic training in people with Prediabetic State, run by Nanjing University of Traditional Chinese Medicine at 2 sites in China.
Trial summary
This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- resistance training and aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2015to Sep 2016
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a confirmed diagnosis of prediabetes according to the American Diabetes Association (ADA) guidelines
- level 4 of muscle strength
- willingness to accept exercise intervention
- provision of written informed consent.
Who cannot join
- type 2 or other types of diabetes
- women who are pregnant
- hepatic dysfunction, as evidenced by alanine aminotransferase (ALT) or alkaline phosphatase (ALP) levels greater than 2.5-fold the upper limits of normal
- crucial organ failure or other severe diseases, including myocardial infarction
- malignancy
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Southeast University, China
Nanjing, Jiangsu, 210096
Hong Ji, 8613511681180, 1059653855@qq.com
- Recruiting
The first Affiliated hospital of Guangxi medical university
Nanning, Guangxi, 530021
Xia Dai, director, 8613977166323, daixia333@aliyun.com
About this study
This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.
Read the detailed description
Most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. It has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and HbA1c level, improve lipid profile, and decrease blood pressure. Based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. Further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.
- Conditions
- Prediabetic State
- Being tested
- resistance training, aerobic training
- Keywords
- resistance training, Prediabetic state, Metabolomics
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingBehavioural
Resistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times.
aerobic trainingBehavioural
Aerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| resistance training | Experimental | Resistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times. Receives: Behavioral: resistance training |
| aerobic training | Experimental | Aerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate. Receives: Behavioral: aerobic training |
| standard care | No intervention | standard care complied with the daily lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months.
Measured: 6 months
glycemic control
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.
Measured: 12 months
Secondary outcomes (4)
small molecule metabolites
Biological markers, with the method of metabolomics approach, will be measured at 6 months
Measured: 6 months
small molecule metabolites
Biological markers, with the method of metabolomics approach, will be measured at 12 months.
Measured: 12 months
Incidence rate of diabetes
Evaluate the incidence of diabetes in prediabetes population at 6 months.
Measured: 6 months
Incidence rate of diabetes
Evaluate the incidence of diabetes in prediabetes population at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangxi Medical University, Southeast University, China
- Responsible party
- Principal investigator, Lou Qingqing, Nanjing University of Traditional Chinese Medicine
- Investigators
- Qingqing Lou, Study director, Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561377
- Sponsor's protocol ID
- 81370923
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Morrison F, Shubina M, Turchin A. Lifestyle counseling in routine care and long-term glucose, blood pressure, and cholesterol control in patients with diabetes. Diabetes Care. 2012 Feb;35(2):334-41. doi: 10.2337/dc11-1635.
PubMed 22275442Lewis GD, Farrell L, Wood MJ, Martinovic M, Arany Z, Rowe GC, Souza A, Cheng S, McCabe EL, Yang E, Shi X, Deo R, Roth FP, Asnani A, Rhee EP, Systrom DM, Semigran MJ, Vasan RS, Carr SA, Wang TJ, Sabatine MS, Clish CB, Gerszten RE. Metabolic signatures of exercise in human plasma. Sci Transl Med. 2010 May 26;2(33):33ra37. doi: 10.1126/scitranslmed.3001006.
PubMed 20505214Strasser B, Siebert U, Schobersberger W. Resistance training in the treatment of the metabolic syndrome: a systematic review and meta-analysis of the effect of resistance training on metabolic clustering in patients with abnormal glucose metabolism. Sports Med. 2010 May 1;40(5):397-415. doi: 10.2165/11531380-000000000-00000.
PubMed 20433212Chen X, Zhao S, Hsue C, Dai X, Liu L, Miller JD, Fang Z, Feng J, Huang Y, Wang X, Lou Q. Effects of aerobic training and resistance training in reducing cardiovascular disease risk for patients with prediabetes: A multi-center randomized controlled trial. Prim Care Diabetes. 2021 Dec;15(6):1063-1070. doi: 10.1016/j.pcd.2021.08.013. Epub 2021 Oct 11.
PubMed 34649825Yan J, Dai X, Feng J, Yuan X, Li J, Yang L, Zuo P, Fang Z, Liu C, Hsue C, Zhu J, Miller JD, Lou Q. Effect of 12-Month Resistance Training on Changes in Abdominal Adipose Tissue and Metabolic Variables in Patients with Prediabetes: A Randomized Controlled Trial. J Diabetes Res. 2019 Oct 16;2019:8469739. doi: 10.1155/2019/8469739. eCollection 2019.
PubMed 31737686
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)
- ClinicalTrials.gov ID
- NCT02561377
- Acronym / sponsor ID
- 81370923
- Conditions
- Prediabetic State
- Keywords
- resistance training, Prediabetic state, Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Guangxi Medical University, Southeast University, China
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Sep 2015 (estimated)
- 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.
This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.
Detailed description
Most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. It has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and HbA1c level, improve lipid profile, and decrease blood pressure. Based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. Further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| resistance training | Experimental | Behavioral: resistance trainingResistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times. |
| aerobic training | Experimental | Behavioral: aerobic trainingAerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate. |
| standard care | No intervention | –standard care complied with the daily lifestyle. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a confirmed diagnosis of prediabetes according to the American Diabetes Association (ADA) guidelines
- level 4 of muscle strength
- willingness to accept exercise intervention
- provision of written informed consent.
Key exclusion criteria (5 listed)
- type 2 or other types of diabetes
- women who are pregnant
- hepatic dysfunction, as evidenced by alanine aminotransferase (ALT) or alkaline phosphatase (ALP) levels greater than 2.5-fold the upper limits of normal
- crucial organ failure or other severe diseases, including myocardial infarction
- malignancy
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 |
|---|---|---|
| resistance trainingResistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times. | Behavioural | resistance training |
| aerobic trainingAerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate. | Behavioural | aerobic training |
Primary outcome
glycemic control
Time frame: 6 months
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months.
glycemic control
Time frame: 12 months
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.
4 secondary outcomes
small molecule metabolites
Time frame: 6 months
small molecule metabolites
Time frame: 12 months
Incidence rate of diabetes
Time frame: 6 months
Incidence rate of diabetes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Background: PubMed 22275442Morrison F, Shubina M, Turchin A. Lifestyle counseling in routine care and long-term glucose, blood pressure, and cholesterol control in patients with diabetes. Diabetes Care. 2012 Feb;35(2):334-41. doi: 10.2337/dc11-1635.
- Background: PubMed 20505214Lewis GD, Farrell L, Wood MJ, Martinovic M, Arany Z, Rowe GC, Souza A, Cheng S, McCabe EL, Yang E, Shi X, Deo R, Roth FP, Asnani A, Rhee EP, Systrom DM, Semigran MJ, Vasan RS, Carr SA, Wang TJ, Sabatine MS, Clish CB, Gerszten RE. Metabolic signatures of exercise in human plasma. Sci Transl Med. 2010 May 26;2(33):33ra37. doi: 10.1126/scitranslmed.3001006.
- Background: PubMed 20433212Strasser B, Siebert U, Schobersberger W. Resistance training in the treatment of the metabolic syndrome: a systematic review and meta-analysis of the effect of resistance training on metabolic clustering in patients with abnormal glucose metabolism. Sports Med. 2010 May 1;40(5):397-415. doi: 10.2165/11531380-000000000-00000.
- Derived from this study: PubMed 34649825Chen X, Zhao S, Hsue C, Dai X, Liu L, Miller JD, Fang Z, Feng J, Huang Y, Wang X, Lou Q. Effects of aerobic training and resistance training in reducing cardiovascular disease risk for patients with prediabetes: A multi-center randomized controlled trial. Prim Care Diabetes. 2021 Dec;15(6):1063-1070. doi: 10.1016/j.pcd.2021.08.013. Epub 2021 Oct 11.
- Derived from this study: PubMed 31737686Yan J, Dai X, Feng J, Yuan X, Li J, Yang L, Zuo P, Fang Z, Liu C, Hsue C, Zhu J, Miller JD, Lou Q. Effect of 12-Month Resistance Training on Changes in Abdominal Adipose Tissue and Metabolic Variables in Patients with Prediabetes: A Randomized Controlled Trial. J Diabetes Res. 2019 Oct 16;2019:8469739. doi: 10.1155/2019/8469739. eCollection 2019.
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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.
Qingqing Lou study director
Nanjing University of Traditional Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training and aerobic training in people with Prediabetic State, run by Nanjing University of Traditional Chinese Medicine at 2 sites in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Contact Qingqing Lou, director (8615312019129, lqq188@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02561377, which also lists 5 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 29 Sep 2015.