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| ID | Type | Description | Link |
|---|---|---|---|
| 2234 | Other Identifier | Instituto Nacional de Ciencias Médicas y Nutrición |
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| Name | Class |
|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body Vibration exercise | Other | Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
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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.
Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerardo RodrÃguez Reyes, MS | Contact | +525559991000 | 13221 | grodriguezreyes@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Rehabilitacion | Recruiting | Mexico City | Mexico City | 14389 | Mexico |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2022 | |
| Reset | Jun 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| D004700 | Endocrine System Diseases |