Diabetes Mellitus, Type 2Phase 3WBVNCT03957811
Effect of Whole-body Vibration on TcPO2
A Phase 3 study testing Whole body Vibration exercise in people with Diabetes Mellitus, Type 2, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Whole body Vibration exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 4 Apr 2017to Jun 2020
- Phase
- Phase 3
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:• Patients with diagnosis of type 2 diabetes less than or equal to six years, under care and having concluded the 4th or 5th medical visit.
- Non-smokers.
- Residents of Mexico City
- Both sexes.
- 40 to 69 years old.
- Agreeing to participate through signature of informed consent.
- HbA1c between 6.0 and 9.0 %.
- Blood pressure less than or equal to130/80.
- Total cholesterol ≤ 240 mg/dL, triglycerides ≤300 mg/dL.
- Stable weight over the last 6 months ( <10% variation).
Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.
- With exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (Wagner 3 or more) or intermittent claudication.
- With important alterations in balance.
- With a recent surgery.
- Gravidity.
- Deep venous thrombosis.
- With pacemaker.
- Recent myocardial ischemia.
- Orthopedic implants.
- Recently-placed mammary prosthesis.
- Exoskeletal prosthesis.
- Discopathies.
- Neoplasia in the last 5 years.
- History of 2 episodes of severe hypoglycemia in the last year.
- Chronic kidney disease with creatinine clearance estimated at <60 ml/min.
- Severe non-proliferative retinopathy, uncontrolled macular edema.
- Hepatic failure (Child-Pugh "C") and/or heart failure (functional Class - NYHA-: III-IV).
- Patients with hemoglobinopathies, severe anemia (≤7.5 g/dL), known hemolytic disease.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Rehabilitacion
Mexico City, Mexico City, 14389
Gerardo Rodriguez Reyes, MS, 5559991000 ext. 13221, grodriguezreyes@gmail.com
About this study
Official title: Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.
Read the detailed description
Objective: To determine the effect of whole body vibration exercise on levels of TcPO2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot.
Material and Methods: controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. Partial pressure of transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group.
Statistical analysis: demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. Comparison between groups will be done with Student t for independent data or Mann-Whitney U when convenient. Baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. For qualitative values, chi square will be used. Multivariate analysis will be performed to control for confounding variables. The level of significance will be a value of 0.05.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Whole body Vibration exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body Vibration exerciseOther
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Subjects under treatment for diabetes will receive the standard treatment for their condition. |
| Intervention | Experimental | Subjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks. Receives: Other: Whole body Vibration exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of whole body vibration on TcPO2 levels
To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start4 Apr 2017
- Primary completion20 Dec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two parallel groups. One will receive the standard treatment for diabetes, and the other will receive standard treatment plus sessions of vibration exercise therapy.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Responsible party
- Principal investigator, Gerardo Rodríguez Reyes, Instituto Nacional de Rehabilitacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957811
- Sponsor's protocol ID
- 2416
- Other IDs
- 2234
- Acronym
- WBV
- Status last verified
- Aug 2019
- First submitted
- 17 May 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
- ClinicalTrials.gov ID
- NCT03957811
- Acronym / sponsor ID
- WBV / 2416
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Collaborators
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 May 2019 (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.
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.
Detailed description
Objective: To determine the effect of whole body vibration exercise on levels of TcPO2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot.
Material and Methods: controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. Partial pressure of transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group.
Statistical analysis: demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. Comparison between groups will be done with Student t for independent data or Mann-Whitney U when convenient. Baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. For qualitative values, chi square will be used. Multivariate analysis will be performed to control for confounding variables. The level of significance will be a value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two parallel groups. One will receive the standard treatment for diabetes, and the other will receive standard treatment plus sessions of vibration exercise therapy.
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Subjects under treatment for diabetes will receive the standard treatment for their condition. |
| Intervention | Experimental | Other: Whole body Vibration exerciseSubjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Whole body Vibration exerciseIntervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks. | Other | Intervention |
Primary outcome
Effect of whole body vibration on TcPO2 levels
Time frame: 12 weeks
To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole body Vibration exercise in people with Diabetes Mellitus, Type 2, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Aug 2019. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gerardo Rodríguez Reyes, MS (+525559991000 ext. 13221, grodriguezreyes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of whole body vibration on TcPO2 levels (time frame: 12 weeks). 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 26 Aug 2019.