Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy

Study Overview
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Brief Summary
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The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.

Detailed Description
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Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1st group and 3rd group will include type 2 diabetic patients with peripheric neuropathy and 2nd group will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.

Official Title
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Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy

Conditions
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Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise

Intervention / Treatment
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* Other: exercise with whole body vibration device
* Other: placebo exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must stand and walk o without using an assistive device. Participants must have HbA1C level below 8.5 Participants must have a weight of less than 120 kg. Exclusion Criteria: T2DM patients with advanced cardiovascular, renal, hepatic disease T2DM patients with diabetic retinopathy or nephropathy T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery T2DM patients with ischemic changes in the resting ECG T2DM patients with untreated hypoglycemia or orthostatic hypotension T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs T2DM patients who have open ulcers or wounds on load-bearing surfaces T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis T2DM patients with active infectious disease T2DM patients with high risk of thrombosis, those with deep vein thrombosis T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant, T2DM patients with a history of cancer T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia T2DM patients with cognitive impairment T2DM patients who are on psychotropic or neurotoxic therapy T2DM patients with advanced balance problems T2DM patients who are pregnant or breastfeeding mothers T2DM patients who are organ transplant recipients T2DM patients with hernia T2DM patients with kidney or bladder stones T2DM patients who are exposed to mechanical vibration due to their job T2DM patients who received insulin therapy during their participation in the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T2DM with neuropathy + WBV<br>Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration | Other: exercise with whole body vibration device<br>* exercise with whole body vibration device<br>|
| Active Comparator: T2DM without neuropathy + WBV<br>Patients without type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration | Other: exercise with whole body vibration device<br>* exercise with whole body vibration device<br>|
| Placebo Comparator: T2DM with neuropathy + land exercise<br>Patients with type 2 Diabetes mellitus with neuropathy who will be trained on land | Other: placebo exercise<br>* exercise without vibration on land<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers | level of CRP | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation