Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2017-04-04
2020-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Controls
Subjects under treatment for diabetes will receive the standard treatment for their condition.
No interventions assigned to this group
Intervention
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.
Whole body Vibration exercise
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
Interventions
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Whole body Vibration exercise
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
69 Years
ALL
No
Sponsors
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Instituto Nacional de Rehabilitacion
OTHER_GOV
Responsible Party
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Gerardo Rodríguez Reyes
Medical Science Researcher
Locations
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Instituto Nacional de Rehabilitacion
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2234
Identifier Type: OTHER
Identifier Source: secondary_id
2416
Identifier Type: -
Identifier Source: org_study_id
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