Skip to main content
OpenTrials
Completed

NCT Number: NCT06033508

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 21600, Turkey (Türkiye)

About this study

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. 60 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 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must stand and walk o without using an assistive device.
  • 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

Treatment and study plan

exercise with whole body vibration device

Other

exercise with whole body vibration device

Placebo Exercise

Other

exercise without vibration on land

Primary outcomes

  1. 6 min walk test

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.