DiabetesNCT02413060
The Impact of Resistance Training on Type 2 Diabetes Patients.
A study testing Resistance training and Lifestyle counselling in people with Diabetes, run by Huashan Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the long-term effects of high-intensity progressive resistance training could improve glucose and lipid metabolism in chinese type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Resistance training and Lifestyle counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- established type 2 diabetes
Who cannot join
- severe joint cardiovascular and respiratory system disease, uncontrolled hypertension (160/90 mmHg), severe diabetic nephropathy and neuropathy
- with severe liver and kidney dysfunction
- with mental system disease
- pregnant women or nursing mothers
Trial locations and contacts
1 site in 1 country.
China1 site
Cao jia du community health service centre
Shanghai, Shanghai Municipality
About this study
The purpose of this study is to determine whether the long-term effects of high-intensity progressive resistance training could improve glucose and lipid metabolism in chinese type 2 diabetes.
- Conditions
- Diabetes
- Being tested
- Resistance training, Lifestyle counselling
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
This training consists 4 exercises and every exercises lasts 5 seconds.
Lifestyle counsellingBehavioural
Lifestyle counselling mainly indicates dietary instruction.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Patients of treatment group will undergo resistance training every week sessions Receives: Other: Resistance training; Behavioral: Lifestyle counselling |
| Lifestyle counseling | Other | Patients of control group will get the lifestyle counseling every 3 month Receives: Behavioral: Lifestyle counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Li, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413060
- Sponsor's protocol ID
- 42500653-9
- Status last verified
- Oct 2015
- First submitted
- 26 Mar 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Resistance Training on Type 2 Diabetes Patients.
- ClinicalTrials.gov ID
- NCT02413060
- Acronym / sponsor ID
- 42500653-9
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 9 Apr 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.
The purpose of this study is to determine whether the long-term effects of high-intensity progressive resistance training could improve glucose and lipid metabolism in chinese type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance training, Behavioral: Lifestyle counsellingPatients of treatment group will undergo resistance training every week sessions |
| Lifestyle counseling | Other | Behavioral: Lifestyle counsellingPatients of control group will get the lifestyle counseling every 3 month |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- established type 2 diabetes
Key exclusion criteria (4 listed)
- severe joint cardiovascular and respiratory system disease, uncontrolled hypertension (160/90 mmHg), severe diabetic nephropathy and neuropathy
- with severe liver and kidney dysfunction
- with mental system disease
- pregnant women or nursing mothers
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 trainingThis training consists 4 exercises and every exercises lasts 5 seconds. | Other | Resistance training |
| Lifestyle counsellingLifestyle counselling mainly indicates dietary instruction. | Behavioural | Lifestyle counseling, Resistance training |
Primary outcome
HbA1c
Time frame: up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Lifestyle counselling in people with Diabetes, run by Huashan Hospital at 1 site 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 1 inclusion and 4 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 14 Oct 2015. 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 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?
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?
HbA1c (time frame: up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.