Effect of Whole-body Vibration on TcPO2

Diabetes Mellitus, Type 2 Clinical Trial

— WBV  

Official title:

Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957811
• Other study ID #: 2416
• Secondary ID: 2234
• Status: Recruiting
• Phase: Phase 3
• Start date: April 4, 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Instituto Nacional de Rehabilitacion
• Contact: Gerardo Rodríguez Reyes, MS
• Phone: +525559991000
• Email: grodriguezreyes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Whole body Vibration exercise
Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Rehabilitacion	Mexico City	DF

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Rehabilitacion	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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