search
Back to results

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

Primary Purpose

Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise with whole body vibration device
placebo exercise
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

T2DM with neuropathy + WBV

T2DM without neuropathy + WBV

T2DM with neuropathy + land exercise

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

inflammatory markers
level of CRP

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT06033508
Brief Title
Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy
Official Title
Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients With and Without Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Diabetic Peripheral Neuropathy, Exercise
Keywords
Type 2 diabetes mellitus, Diabetic Peripheral Neuropathy, whole body vibration, inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T2DM with neuropathy + WBV
Arm Type
Active Comparator
Arm Description
Patients with type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration
Arm Title
T2DM without neuropathy + WBV
Arm Type
Active Comparator
Arm Description
Patients without type 2 Diabetes mellitus with neuropathy who will be trained by whole body vibration
Arm Title
T2DM with neuropathy + land exercise
Arm Type
Placebo Comparator
Arm Description
Patients with type 2 Diabetes mellitus with neuropathy who will be trained on land
Intervention Type
Other
Intervention Name(s)
exercise with whole body vibration device
Intervention Description
exercise with whole body vibration device
Intervention Type
Other
Intervention Name(s)
placebo exercise
Intervention Description
exercise without vibration on land
Primary Outcome Measure Information:
Title
inflammatory markers
Description
level of CRP
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GULIN FINDIKOGLU, MD PhD
Phone
90 258 2966000
Ext
4956
Email
gulin_dr@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fulden Ozturk, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GULIN FINDIKOGLU, Assoc Prof
Organizational Affiliation
Pamukkale University, Medical Faculty, PMR Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
21600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs