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

Sponsor

Pamukkale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033508

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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), interleukin-6 (IL-6), interleukin -10 (IL_10), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Diabetic Peripheral Neuropathy Exercise	Other: exercise with whole body vibration device Other: placebo exercise	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: T2DM with neuropathy + WBV

Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration

Other: exercise with whole body vibration device

exercise with whole body vibration device

Active Comparator: T2DM without neuropathy + WBV

Patients without type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration

Other: exercise with whole body vibration device

exercise with whole body vibration device

Placebo Comparator: T2DM with neuropathy + land exercise

Patients with type 2 Diabetes mellitus with neuropathy who will be trained on land

Other: placebo exercise

exercise without vibration on land

Outcome Measures

Primary Outcome Measures

inflammatory markers [12 weeks]
level of CRP

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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